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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/Prescription Drugs

Amneal Methotrexate Tablets Recalled for Potential Foreign Tablet Presence

Agency Publication Date: August 8, 2024
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Summary

Amneal Pharmaceuticals, LLC is recalling 12,624 bottles of Methotrexate (2.5 mg) tablets because some bottles may contain a different medication called Fludrocortisone Acetate (0.1 mg). The recall involves 100-count bottles from a single lot (BB29124) with an expiration date of February 2026. Methotrexate is used to treat certain cancers and autoimmune conditions, while Fludrocortisone is a corticosteroid; finding the wrong pill in your bottle could lead to taking the incorrect medication or missing a required dose.

Risk

If a patient accidentally takes Fludrocortisone instead of Methotrexate, they may experience side effects from the corticosteroid while their underlying condition remains undertreated. No incidents or injuries have been reported to date in connection with this issue.

What You Should Do

  1. This recall affects Methotrexate Tablets, USP, 2.5 mg, sold in 100-count bottles (NDC 69238-1423-1) with Lot number BB29124 and an expiration date of 02/28/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals, LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Methotrexate Tablets, USP, 2.5mg (100-count Bottle)
Variants: 2.5mg, Tablet
Lot Numbers:
BB29124 (Exp. 02/28/2026)
NDC:
69238-1423-1

Distributed By Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95082
Status: Resolved
Manufacturer: Amneal Pharmaceuticals, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 12,624 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.