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Drug FDA Class III Completed Foreign material

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Amneal Pharmaceuticals, LLC Published Aug 14, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 35/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amneal Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Hazards

Fludrocortisone Acetate Tablets · primary

Affected products (1)

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

12,624 bottles

Lot codes: BB29124
Code info: Lot # BB29124, Exp. 02/28/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 1, 2024
  2. Published
    Aug 14, 2024
Recall number
D-0629-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.