Recall: D-0774-2026

Class II - Potentially Harmful

Class IIClassification

2026-07-24Initiated

OngoingStatus

Mylan Pharmaceuticals IncFirm

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

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.