FDAClass IIAugust 26, 2026

Acamprosate Calcium recall: Failed Dissolution

Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan…

Why was Acamprosate Calcium recalled?

Failed Dissolution Specifications

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80

Product
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan…
Recalling firm
Mylan Pharmaceuticals Inc
Distribution
US Nationwide.
Recall date
August 26, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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