Acamprosate Calcium recall (Mylan Pharmaceuticals Inc)
DrugClass IIOngoing
Summary: Mylan Pharmaceuticals Inc is recalling 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.
What is being recalled
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.
Why
Failed Dissolution Specifications
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0774-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 24, 2026 |
| Reported | August 26, 2026 |
| Company | Mylan Pharmaceuticals Inc |
| Company location | Morgantown, WV, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Mylan Pharmaceuticals Inc · all drug recalls · recalls from July 2026