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.
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 18
CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot #'s 52J17, 53J17, 54J17, 55J17, 59J17, 60J17 EXP 07/2019
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot #36P17 EXP 11/2019
Distribution pattern
Distributed Nationwide in the USA
drug · product 3 of 18
CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot #63J17 EXP 07/2019, 11P17 EXP 11/2019
Distribution pattern
Distributed Nationwide in the USA
drug · product 9 of 18
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot #56J17 EXP 07/2019
Distribution pattern
Distributed Nationwide in the USA
drug · product 12 of 18
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot #57J17 EXP 07/2019
Distribution pattern
Distributed Nationwide in the USA
drug · product 13 of 18
CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot #'s 09K17, 13K17 EXP 08/2019
Distribution pattern
Distributed Nationwide in the USA
drug · product 15 of 18
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot # 14L18, EXP 09/2020
Distribution pattern
Distributed Nationwide in the USA
drug · product 16 of 18
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information
Lot # a) 21J18, EXP 07/2021 b) 42H18, EXP 06/2021; c) 32H18, EXP 6/2021
Distribution pattern
Distributed Nationwide in the USA
drug · product 18 of 18
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of Specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
