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.
Product description
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Lot numbers, UPCs & expiration codes
Lot # BB29124, Exp. 02/28/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0629-2024
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Aug 1, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 12,624 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0629-2024, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 95082
- Address
- 400 Crossing Blvd Fl 3
- Code information
- Lot # BB29124, Exp. 02/28/2026
- Postal code
- 08807-2863
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0629-2024
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product quantity
- 12,624 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2024