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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88677

19 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 01, 2021
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
Bayer Healthcare Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

19 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 19

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

D-0236-2022
Recall number
D-0236-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
2,817,468 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # TN00082, Exp 9/30/2021;TN000TU, TN000TV, Exp. 10/31/2021; TN00236, Exp. 1/31/2022; TN003C8, Exp 2/28/2022; TN003C9, Exp 3/31/2022; TN003GS, Exp 4/30/2022; TN0041W, Exp 6/30/2022; TN006W8, Exp 8/31/2022; TN005P5, Exp 9/30/2022; TN006MZ, Exp 2/28/2023;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 2 of 19

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

D-0237-2022
Recall number
D-0237-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
4,546,152 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot #: CV01BEP, 3/31/2022; CV01D6W, 5/31/2022; CV01EV0, 7/31/2022; TN0004J, 9/30/2022; TN001AE, 11/30/2022; TN003C3, 1/31/2023; TN003C4, 2/28/2023; TN003HT, 3/31/2023; TN003CW, 4/30/2023; TN0045J, 6/30/2023; TN0040C, 7/31/2023; TN004BU, 8/31/2023; TN006MB, 9/30/2022;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 3 of 19

LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,

D-0238-2022
Recall number
D-0238-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
3,816,468 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # (a) CV017D9, EXP 10/31/2021; CV01940, EXP 11/30/2021; CV01CD9, EXP 4/30/2022; CV01D9T, CV01DZ3, EXP 6/30/2022; CV01EPP, EXP 7/31/2022; TN000TT, EXP 10/31/2022; TN003CG, EXP 1/31/2023; TN003CH, TN00407, EXP 3/31/2023; TN0041V, EXP 6/30/2023; TN0056W, EXP 7/31/2022; TN005P4, EXP 8/31/2022; TN006MJ, EXP 9/30/2022; (b) CV01940, CV01940A, EXP 11/30/2021; CV01AP2, EXP 02/28/2022; CV01D9T, CV01D9TA, CV01DZ3, EXP 06/30/2022; CV01EPP, EXP 07/31/2022; TN005P4, EXP 08/31/2022; TN000TT, TN000TTA, EXP 10/31/2022; TN003CG, EXP 01/31/2023; TN003CH, TN003CHA, TN00407, TN006TD, TN006TDB, TN00407A, EXP 03/31/2023; TN0041V, EXP 06/30/2023

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 4 of 19

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.

D-0239-2022
Recall number
D-0239-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
77,076 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # TN005K4, EXP 4/30/2022; TN005K8, EXP 6/30/2022

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 5 of 19

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,

D-0240-2022
Recall number
D-0240-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
579,456 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # (a)TN0023C, EXP 1/31/2022; TN003C7, EXP 4/30/2022; TN00570, EXP 7/31/2022; TN0056Z, TN005KJ, EXP 8/31/2022; (b)TN0023C, EXP 01/31/2022; TN003C7, EXP 04/30/2022; TN0023DV, TN0023DAV, TN0023DBV, TN0023DC, EXP 02/28/2022; TN005KJ, TN005KJA, TN005KJB, EXP 08/31/2022;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 6 of 19

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain

D-0241-2022
Recall number
D-0241-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
1,801,332 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # (a) TN000TR, EXP 10/31/2021; TN0011B, EXP 11/30/2021; TN003CC, TN003CD, EXP 02/28/2022; TN0040B, EXP 05/31/2022; TN0041U, EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN005P3, EXP 10/31/2022; TN006AP, TN006MC, EXP 01/31/2023; TN006TB, EXP 04/30/2023; (b) TN000TR, EXP 10/31/2021; TN0011B, TN0011BA, EXP 11/30/2021; TN003CD, TN003CDA, TN003CDB,EXP 02/28/2022; TN0040BA, TN0040BV, EXP 05/31/2022; TN0041U,EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN006MC, EXP 01/31/2023;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 7 of 19

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981

D-0242-2022
Recall number
D-0242-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
738,432 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # (a) TN004BW, EXP 7/31/2022, (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 8 of 19

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

D-0243-2022
Recall number
D-0243-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
4,990,860 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # (a)TN0060U, TN0060V, TN0060W, EXP 7/31/2022; TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022; TN006YW, EXP 10/31/2022; TN006MY, TN006YX, TN006YY, EXP 12/31/2022; TN007EN, TN007EP, TN007ER, EXP 2/28/2023; (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021; CV017XS, EXP 11/30/2021; CV01980, CV019DS, EXP 12/31/2021; CV01A72, CV01A73, CV01AE6, EXP 1/31/2022; CV01AUA, CV01B1E, EXP 2/28/2022; CV01BNE, EXP 3/31/2022; CV01BVU, EXP 3/31/2022; CV01CT6, CV01CY1, EXP 4/30/2022; CV01D2G, EXP 5/31/2022; CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022; CV01E2W, CV01E2X, EXP 7/31/2022; CV01E2U, EXP 7/31/2022; CV01E2V, EXP 8/31/2022; TN001V6, EXP 11/30/2022; TN00243, EXP 12/31/2022; TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, EXP 1/31/2023; TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022, (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 9 of 19

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

D-0244-2022
Recall number
D-0244-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
592,416 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # TN00086, CV015YU, EXP 10/31/2022; TN00273, EXP 12/31/2022; TN005RW, Exp 5/31/2023;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 10 of 19

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

D-0245-2022
Recall number
D-0245-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
2,841,012 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # (a) CV015YT, EXP 10/31/2021; CV01AE7, EXP 2/28/2022; CV01CY2, EXP 4/30/2022'; CV01E6P, EXP 8/31/2022; TN00085, TN001EK, EXP 10/31/2022; TN001ZV, TN00274, EXP 12/31/2022; TN003CU, EXP 1/31/2023; TN003CV, EXP 3/31/2023; TN0047H, EXP 4/30/2023; TN0047R, EXP 5/31/2023; (b)TN0067B, EXP 9/30/2022; TN006AT, EXP 12/31/2022; TN006TA, EXP 2/28/2023; (c) CV01E6PV, CV01E6PD, CV01E6PC, CV01E6PBV, CV01E6PAV, EXP 8/31/2022

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 11 of 19

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

D-0246-2022
Recall number
D-0246-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
2,817,468 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # TN008D3, TN009K7, Exp 5/31/2023.

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 12 of 19

LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

D-0247-2022
Recall number
D-0247-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
4,546,152 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # CV018TV, 11/30/2021; CV01A71, 1/31/2022; CV01CK4, 4/30/2022; TN0023G, 12/31/2022; TN006TC, 1/31/2023; TN007TG, 3/31/2023; TN008CZ, 4/30/2023; TN008CY, 4/30/2023.

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 13 of 19

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

D-0248-2022
Recall number
D-0248-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
3,816,468 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # CV01AP2, EXP 2/28/2022; TN006TD, EXP 3/31/2023; TN008CV, EXP 4/30/2023; TN008CW, EXP 5/31/2023;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 14 of 19

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.

D-0249-2022
Recall number
D-0249-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
579,456 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # TN0023D, EXP 2/28/2022; TN004BX, EXP 6/30/2022;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 15 of 19

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105

D-0250-2022
Recall number
D-0250-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
738,432 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # TN0067A, EXP 2/28/2023; TN008CU, EXP 4/30/2023;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 16 of 19

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

D-0251-2022
Recall number
D-0251-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
4,990,860 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # (a)TN006MX, EXP 10/31/2022; TN00BKV, TN008D1, TN008D2, EXP 3/31/2023; (b) CV0180B, EXP12/31/2021; TN003C5, EXP 1/31/2023

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 17 of 19

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

D-0252-2022
Recall number
D-0252-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
592,416 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # TN008M0, EXP 4/30/2023

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 18 of 19

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

D-0253-2022
Recall number
D-0253-2022
Initiated
October 01, 2021
Classification
Class I
Status
Terminated
Quantity
2,841,012 cans

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Chemical Contamination: presence of benzene

Code information

Lot # (a)CV015YS, EXP 9/30/2021 (b) TN008CT, TN007TJ, EXP 3/31/2023

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

drug · product 19 of 19

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

D-0254-2022
Recall number
D-0254-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Quantity
579,456 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
contaminated with benzene
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information

Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022;

Distribution pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Field note

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