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Acamprosate Calcium recall

Mylan Pharmaceuticals Inc recalled Acamprosate Calcium on August 26, 2026 because of failed dissolution specifications. It was sold nationwide.

Why it was recalled

Failed Dissolution Specifications

What's recalled

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.

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Mylan Pharmaceuticals Inc, Morgantown, WV
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0774-2026
Source
U.S. Food and Drug Administration

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