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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Famotidine 40mg Recalled for Presence of Ibuprofen and Famotidine 20mg

Agency Publication Date: February 26, 2021
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Summary

Aurobindo Pharma USA Inc. has recalled 1,296 bottles of Famotidine Tablets USP 40mg (famotidine), a prescription medication used to treat heartburn and acid reflux. This recall was initiated because bottles labeled as 40mg tablets were found to contain foreign tablets, specifically Ibuprofen 400mg and Famotidine 20mg. Consuming the incorrect medication could lead to unintended side effects or lack of proper treatment for your condition. These products were distributed in Texas, California, Georgia, and Pennsylvania in 1,000-count bottles.

Risk

Taking ibuprofen when expecting famotidine can cause serious health risks, including allergic reactions or stomach bleeding, especially for those with pre-existing conditions or those taking other medications. Additionally, receiving a lower dose of famotidine (20mg instead of 40mg) may result in the ineffective treatment of gastrointestinal conditions.

What You Should Do

  1. Check your medication bottle for Famotidine Tablets USP 40mg, 1,000-count bottles with NDC 65862-860-99.
  2. Verify if your bottle belongs to Lot Number P2000467 with an expiration date of 7/2022.
  3. If you have the affected medication, stop taking it immediately and contact your healthcare provider or pharmacist for guidance.
  4. Return any unused product to your pharmacy for a refund and contact Aurobindo Pharma USA Inc. for further instructions.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Consult healthcare provider and return to pharmacy.

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

Affected Products

Product: Famotidine Tablets USP 40mg (1,000-count bottle)
Model:
NDC 65862-860-99
Recall #: D-0290-2021
Lot Numbers:
P2000467 (Exp 7/2022)
Date Ranges: Expiration 7/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87193
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 1296 bottles
Distributed To: Texas, California, Georgia, Pennsylvania

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.