FDAFDA recall D-0774-2026 · Aug 26, 2026
Mylan Pharmaceuticals Inc: Acamprosate Calcium recall
Recall found
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 for recall
Failed Dissolution Specifications
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Distribution
- US Nationwide.
- Recalling firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-24
Source: openFDA enforcement record D-0774-2026 · search recall number D-0774-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.