FDA Drugs recall ·
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles… recall
- Recall number
- D-0774-2026
- Date
- (initiated July 24, 2026)
- Company / brand
- Mylan Pharmaceuticals Inc
3711 Collins Ferry Rd, Morgantown, WV, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0774-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.