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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 12,624
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.
Related recalls
Same manufacturer · Amneal Pharmaceuticals, LLC
See all →- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModeratePrimidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
FDA (Drugs) · 2026-06-17
- SevereMagnesium sulfate pouch recalled as Class I for containing tranexamic acid
FDA (Drugs) · 2026-04-08
- HighAmneal tramadol tablets failed nitrosamine impurity specification at stability
FDA (Drugs) · 2026-04-08
- ModerateChlorpromazine 100 mg tablets recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-10
Same hazard · drug contamination
See all →- ModerateMedline Convenience Kits recalled for defective Lidocaine Ampules
FDA (Devices) · 2026-07-08
Similar recalls
- HighAmneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity
FDA (Drugs) · 2024-02-14
- SevereAmneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
FDA (Drugs) · 2020-07-01
- SevereAmneal Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-07-01
- SevereSulfamethoxazole and Trimethoprim Tablets Recalled for Microbial Contamination
FDA (Drugs) · 2025-06-18
- ModerateAmneal Recalls Methylergonovine Maleate Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2019-07-31
- SevereLetrozole Tablets Recalled for Potential Mislabeling as Metoprolol Tartrate
FDA (Drugs) · 2014-01-22