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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

Methotrexate Tablets Recalled for Failed Tablet Identification and Scoring

Agency Publication Date: October 23, 2023
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Summary

West-Ward Columbus Inc. is recalling 2,673 cartons of Methotrexate Tablets (2.5 mg) because some tablets were found to have an unsmooth surface or illegible identification markings and scoring. Methotrexate is a prescription medication used to treat certain types of cancer and severe skin or joint conditions. This voluntary recall affects three specific lots distributed in Mississippi and Ohio.

Risk

Illegible identification markings on medication can lead to confusion about the drug's identity, while illegible scoring may cause patients to split the tablets incorrectly, potentially leading to inaccurate dosing.

What You Should Do

  1. The recalled products are Methotrexate Tablets, USP, 2.5 mg, packaged in 10x10 unit-dose cartons (NDC 0054-8550-25) under lots AB7486B (exp Dec 2023), AB8766B (exp April 2024), and AB9484B (exp Aug 2024).
  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 West-Ward Columbus Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 (2.5 mg)
Variants: 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only
Lot Numbers:
AB7486B (Exp Dec 2023)
AB8766B (Exp April 2024)
AB9484B (Exp Aug 2024)
NDC:
0054-8550-25

Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. Recall #: D-0066-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93223
Status: Active
Manufacturer: West-Ward Columbus Inc
Sold By: West-Ward Pharmaceuticals Corp.
Manufactured In: United States
Units Affected: 2,673 cartons
Distributed To: Mississippi, Ohio

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.