FDA recall, , Moderate risk
Mylan Acamprosate Calcium, Delayed-Release Tablets
Acamprosate Calcium, Delayed-Release Tablets failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Mylan Pharmaceuticals Inc., of Morgantown, West Virginia, recalled Acamprosate Calcium, Delayed-Release Tablets, 333 mg, in 180-tablet bottles, because the product failed dissolution specifications. The recall began July 24, 2026, and the product was distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Acamprosate Calcium, Delayed-Release Tablets
- NDC
- 0378-6333-80
- Lot code
- 3227809
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- MYLAN PHARMACEUTICALS INCMorgantown, West Virginia
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99483
- Recall number
- D-0774-2026
All recalls from MYLAN PHARMACEUTICALS INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
