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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83908

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

Open FDA event record

Event summary

Timeline bucket
October 01, 2019
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Dr. Reddy's Laboratories, 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

18 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 18

Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)

D-0168-2020
Recall number
D-0168-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 2 of 18

Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720

D-0169-2020
Recall number
D-0169-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 3 of 18

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC

D-0170-2020
Recall number
D-0170-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 4 of 18

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

D-0171-2020
Recall number
D-0171-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 5 of 18

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

D-0172-2020
Recall number
D-0172-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 6 of 18

Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC

D-0173-2020
Recall number
D-0173-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 7 of 18

Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

D-0174-2020
Recall number
D-0174-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 8 of 18

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

D-0175-2020
Recall number
D-0175-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 9 of 18

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

D-0176-2020
Recall number
D-0176-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 10 of 18

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.

D-0177-2020
Recall number
D-0177-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 11 of 18

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

D-0178-2020
Recall number
D-0178-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 12 of 18

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

D-0179-2020
Recall number
D-0179-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 13 of 18

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

D-0180-2020
Recall number
D-0180-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 14 of 18

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

D-0181-2020
Recall number
D-0181-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 15 of 18

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

D-0182-2020
Recall number
D-0182-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 16 of 18

Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

D-0183-2020
Recall number
D-0183-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 17 of 18

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

D-0184-2020
Recall number
D-0184-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

drug · product 18 of 18

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

D-0185-2020
Recall number
D-0185-2020
Initiated
October 01, 2019
Classification
Class II
Status
Completed
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

Batch Numbers: All lots within expiry.

Distribution pattern

Product was distributed to major distributors throughout the United States who may have further distributed the product.

Field note

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