United StatesAcamprosate Calcium delayed‑release tablets, 333 mg, 180‑tablet bottles (Rx only), NDC 0378-6333-80, Lot 3227809, expiry 10/2026, manufactured and recalled by Mylan Pharmaceuticals Inc., Morgantown, WV, are affected. They were recalled because they failed dissolution specifications; the recall is ongoing and the product was distributed nationwide in the United States.
What's 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.
Recalling firm: Mylan Pharmaceuticals Inc, Morgantown, WV, United States.
How to identify it
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
The hazard
Failed Dissolution Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)