FDA-Drug2026-08-26Class IIPROCESSING DEFECT
Mylan Acamprosate Calcium tablets recalled for failed dissolution specifications
What this means
Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.
- Check if your Acamprosate Calcium matches lot #3227809 (expiring 10/2026, NDC 0378-6333-80).
- Contact your pharmacy or doctor if you have this lot; do not stop taking your medication without medical guidance.
- Your pharmacy or doctor can provide a replacement or alternative treatment.
The agency's original wording
Hazard
Failed Dissolution Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Manufactured in
3711 Collins Ferry Rd, Morgantown, WV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2026More Mylan recalls
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