Mylan recalls acamprosate calcium delayed-release tablets because they failed dissolution tests
The 333 mg tablets failed dissolution specifications, meaning they may not release the medicine into the body as intended.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- Mylan Pharmaceuticals Inc
- Hazard
- Failed Dissolution Specifications
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- August 19, 2026
- Recall started
- July 24, 2026
- FDA enforcement report
- August 26, 2026
- Identifiers
- Codes: Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- FDA recall number: D-0774-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
Related recalls
Mylan recalls Amnesteem isotretinoin 40 mg capsules because they failed dissolution testing
The capsules failed dissolution testing, meaning they did not break down and release the medicine as required, and the notice covers 34850 blister packs sold nationwide in the United States.
Mylan Pharmaceuticals INC · 34850 blister packs
Mylan recalls Prasugrel 10mg tablets because they failed a dissolution test
The tablets failed a test of how well they dissolve at the 18-month stability check, so they did not meet required standards.
Mylan Pharmaceuticals Inc · 47,662 bottles