Why it was recalled
Failed Dissolution Specifications
Product description
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
Lot numbers, UPCs & expiration codes
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
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-0774-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 24, 2026
- FDA report date
- Aug 26, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0774-2026, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 99483
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Postal code
- 26505-2362
- Report date
- Aug 26, 2026
- Product type
- Drugs
- Recall number
- D-0774-2026
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jul 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2026