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Class II Recall
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
Status
Ongoing
Lot
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
Date
2026-08-26
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.