Class IIDrug
Acamprosate Calcium recall
Summary
Mylan Pharmaceuticals Inc is recalling Acamprosate Calcium (drug). According to the FDA report, the reason is: Failed Dissolution Specifications. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Lot / code info
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Quantity
- Not listed
- Distribution
- US Nationwide.
- Recalling company
- Mylan Pharmaceuticals Inc, Morgantown, WV United States
- Recall started
- July 24, 2026
- FDA report date
- August 26, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0774-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Mylan Pharmaceuticals Inc) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.