D-0774-2026 Class II Ongoing
FDA drug recall D-0774-2026 was initiated by Mylan Pharmaceuticals Inc on July 24, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- July 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Distribution Pattern
US Nationwide.
Code Information
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80