Amneal recalls 2.5mg methotrexate tablets (100-count) due to potential fludrocortisone acetate tablets inside. This could cause unintended hormone effects. Return or contact for details.
“Amneal Methotrexate Tablets Recall: Foreign Fludrocortisone Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32576-amneal-methotrexate-tablets-recall-foreign-fludrocortisone-risk. Based on FDA recall #D-0629-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0629-2024%22&limit=1).
Amneal Pharmaceuticals LLC voluntarily recalled Methotrexate Tablets USP, 2.5mg, 100-count bottles distributed nationwide due to the potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg, according to the FDA on Aug. 1, 2024.
How to tell if you have it
Brand: Amneal
Product: Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only
The recall addresses the potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle, according to the FDA.
Context
GovInfoNow's records show Amneal Pharmaceuticals LLC has 9 other recalls on record since Dec. 12, 2016. Other recent recalls of similar products include Amneal Estradiol Gel Recall (Sept. 8, 2026), Amneal Recalls Primidone Tablets Due to Cross-Contamination Risk (June 3, 2026), and Amneal traMADol 50mg Tablets Recall (March 19, 2026). Other recent recalls of similar products include Amerisource Health Primidone Tablets Recall (May 1, 2026), Bionpharma Divalproex Tablets Recall (June 26, 2026), and Golden State Baclofen Tablets Recall (Nov. 26, 2025).
How to tell if you have this one
Check for the 2.5mg methotrexate tablets (100-count) with NDC# 69238-1423-1 and lot number BB29124. The product was distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.
Brand
Amneal
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Product
Immediately stop using the recalled methotrexate tablets if you have them.
Contact Amneal
Reach out to Amneal Pharmaceuticals for instructions on returning the product or getting a replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 13 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0629-2024 (August 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0629-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.