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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

AAA Pharmaceutical, Inc.: Ranitidine 150 mg Tablets Recalled Due to NDMA Impurity

Agency Publication Date: January 6, 2020
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Summary

AAA Pharmaceutical, Inc. is recalling approximately 65,808 bottles of Ranitidine 150 mg tablets (the generic version of Zantac) because the active ingredient contains an impurity known as N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen, and its presence in the medication was discovered during testing. The recall includes 34,272 bottles of 24-count tablets and 31,536 bottles of 130-count tablets sold at various retail locations. If you are taking this medication, you should consult with your doctor or pharmacist to discuss alternative treatments.

Risk

NDMA is an environmental contaminant that is classified as a probable human carcinogen. While NDMA can be found in water and foods, chronic exposure to higher-than-acceptable levels in medications may increase the risk of cancer over time.

What You Should Do

  1. Identify your product by checking the bottle for Ranitidine 150 mg tablets with NDC 37808-196-01 (24-count) or NDC 37808-196-04 (130-count).
  2. Check the bottle label for the following lot numbers and expiration dates: P134458 (Sept 2020), P134943 (Aug 2020), P135840 (Aug 2020), P136622 (April 2021), P136871 (April 2021), P137347 (April 2021), or P137424 (April 2021) for 24-count bottles.
  3. For 130-count bottles, check for lot numbers: P134457 (Sept 2020), P135156 (Aug 2020), P135243 (Aug 2020), P135877 (Sept 2020), P136145 (Aug 2020), P136146 (Sept 2020), P136623 (April 2021), P136728 (April 2021), P136994 (April 2021), P137348 (April 2021), P137423 (April 2021), or P137499 (April 2021).
  4. If your product is affected, stop using it immediately and contact your healthcare provider or pharmacist to discuss safe alternative treatments for your condition.
  5. Return any unused portion of the recalled medication to the place of purchase for a full refund.
  6. For questions regarding this recall, you may contact AAA Pharmaceutical, Inc. at their Lumberton, New Jersey location or contact the FDA Consumer Complaint coordinator at 1-888-723-3332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund upon return of product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Ranitidine 150 mg tablets (24 count bottles)
Model:
NDC 37808-196-01
Lot Numbers:
P134458 (Exp Sept 2020)
P134943 (Exp Aug 2020)
P135840 (Exp Aug 2020)
P136622 (Exp April 2021)
P136871 (Exp April 2021)
P137347 (Exp April 2021)
P137424 (Exp April 2021)
Product: Ranitidine 150 mg tablets (130 count bottles)
Model:
NDC 37808-196-04
Lot Numbers:
P134457 (Exp Sept 2020)
P135156 (Exp Aug 2020)
P135243 (Exp Aug 2020)
P135877 (Exp Sept 2020)
P136145 (Exp Aug 2020)
P136146 (Exp Sept 2020)
P136623 (Exp April 2021)
P136728 (Exp April 2021)
P136994 (Exp April 2021)
P137348 (Exp April 2021)
P137423 (Exp April 2021)
P137499 (Exp April 2021)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84583
Status: Resolved
Manufacturer: AAA Pharmaceutical, Inc.
Sold By: retail stores
Manufactured In: United States
Units Affected: 2 products (34,272 (24-count bottles); 31,536 (130-count bottles))
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.