Methotrexate tablets may contain wrong medication, FDA says
Amneal Pharmaceuticals recalls Methotrexate 2.5mg tablets (Lot BB29124) distributed nationwide due to potential presence of Fludrocortisone Acetate tablets. Patients should verify their lot number with their pharmacy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III precautionary recall with no reported illnesses or injuries. Although medication mix-up is a serious potential hazard, the precautionary nature based on potential rather than confirmed contamination and absence of harm places this in the moderate category.
Plain-English summary
Amneal Pharmaceuticals is recalling Methotrexate Tablets, USP, 2.5mg in 100-count bottles due to the potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg mixed within the bottles. This could result in patients receiving the wrong medication.
The recall affects Lot BB29124 (expiration 02/28/2026) of 12,624 bottles distributed nationwide in the USA. The product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ (NDC# 69238-1423-1).
Patients currently taking Methotrexate from this lot should contact their pharmacy immediately to verify their lot number. Do not continue taking tablets from Lot BB29124 without confirming the lot number with your pharmacy. Consult with your healthcare provider before making any changes to your medication.
The recalled product
- Product
- Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- drug-contamination
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # BB29124
- Exp. 02/28/2026
Distribution
Distributed nationwide across the United States.
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