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

Dr. Reddy's Laboratories, Inc.: Famotidine Tablets Recalled Due to Impurity and Degradation Issues

Agency Publication Date: October 11, 2017
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Summary

Dr. Reddy's Laboratories is recalling 569,376 bottles of Famotidine tablets (10 mg), an over-the-counter acid controller sold under the CVS Pharmacy and Equate brands. The recall was initiated because routine stability testing found that a specific impurity (Impurity 8) exceeded safety specifications after 24 months. These products were distributed nationwide in 30-count bottles. Consumers who have these products should stop using them and contact a healthcare professional.

Risk

The product failed stability testing for an individual related substance, which means the medication may contain levels of degradation impurities that exceed the approved safety limits over time.

What You Should Do

  1. Check your medicine cabinet for Famotidine tablets (10 mg) in 30-count bottles labeled as CVS Pharmacy Acid Controller (NDC 55111-118-30) or Equate Famotidine (NDC 49035-118-30).
  2. If you have the CVS brand, check for the following lot numbers and expiration dates: 79C408882B, 79C408884C, 79C408886B (Exp 10/17); 79C501523B, 79C501524B (Exp 01/18); and 79C502318B (Exp 3/18).
  3. If you have the Equate brand, check for the following lot numbers and expiration dates: 79C408885B, 79C408886A (Exp 10/17); 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B (Exp 01/18); 79C502317A (Exp 3/18); 79C504087B, 79C504088A (Exp 5/18); and 79C505926A (Exp 7/18).
  4. Stop using the affected medication immediately and contact your healthcare provider or pharmacist for guidance regarding alternative treatments.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Dr. Reddy's Laboratories at their Princeton, NJ headquarters for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: CVS Pharmacy Acid Controller (Famotidine tablets, 10 mg), 30-count bottle
Model:
NDC 55111-118-30
Lot Numbers:
79C408882B (Exp 10/17)
79C408884C (Exp 10/17)
79C408886B (Exp 10/17)
79C501523B (Exp 01/18)
79C501524B (Exp 01/18)
79C502318B (Exp 3/18)
Date Ranges: Exp 10/17, Exp 01/18, Exp 3/18
Product: Equate Famotidine (Famotidine tablets, 10 mg), 30-count bottle
Model:
NDC 49035-118-30
Lot Numbers:
79C408885B (Exp 10/17)
79C408886A (Exp 10/17)
79C500967 (Exp 01/18)
79C501523C (Exp 01/18)
79C501525A (Exp 01/18)
79C501525B (Exp 01/18)
79C501525C (Exp 01/18)
79C501526B (Exp 01/18)
79C502317A (Exp 3/18)
79C504087B (Exp 5/18)
79C504088A (Exp 5/18)
79C505926A (Exp 7/18)
Date Ranges: Exp 10/17, Exp 01/18, Exp 3/18, Exp 5/18, Exp 7/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78220
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: CVS Pharmacy; Walmart
Manufactured In: India, United States
Units Affected: 569376 bottles
Distributed To: Nationwide

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.