Mylan Pharmaceuticals Inc recalls Acamprosate Calcium
- Recalling company
- Mylan Pharmaceuticals Inc
- Product
- 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.
- Reason
- Failed Dissolution Specifications
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 24, 2026
- Reported
- Aug 26, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Lot / codes
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Company location
- Morgantown, WV
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0774-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0774-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.