FDAFDA · Food and drugs·Recall number D-0774-2026
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.
Published August 26, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACAMPROSATE CALCIUM
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- US Nationwide.
- UPC
- 0303786333806
- Lot
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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