FDA recall D-0774-2026

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 for recall

Failed Dissolution Specifications

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-07-24

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2026