Why it was recalled
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Product description
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Lot numbers, UPCs & expiration codes
Lot # AC2556A; Exp. 03/2027
Where it was sold
US Nationwide.
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-0183-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 19, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 2591 100-count boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-0183-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 95999
- Address
- 1809 Wilson Rd
- Code information
- Lot # AC2556A; Exp. 03/2027
- Postal code
- 43228-9579
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0183-2025
- Classification
- Class III
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 2591 100-count boxes
- Reason for recall
- Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Dec 19, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 3, 2025