Methotrexate Tablets recall
FDA recall D-0629-2024 · initiated Aug 1, 2024
Amneal Pharmaceuticals, LLC recalled Methotrexate Tablets in Aug 2024 — an FDA Class III recall (D-0629-2024) because Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12,624 bottles
Details
- Product
- Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
- Recalling company
- Amneal
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 1, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was Methotrexate Tablets recalled?
- Amneal Pharmaceuticals, LLC recalled Methotrexate Tablets in Aug 2024 — an FDA Class III recall (D-0629-2024) because Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Methotrexate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0629-2024 was: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
- Is a recalled Methotrexate Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Methotrexate Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # BB29124, Exp. 02/28/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0629-2024.