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Class II · ModerateActive recall

Acamprosate Calcium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# 3227809; Expiry:10/2026; NDC #: [redacted-phone]
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Pharmaceuticals Inc.
Brand nameACAMPROSATE CALCIUM
Generic nameACAMPROSATE CALCIUM ENTERIC-COATED
Active ingredient(s)ACAMPROSATE CALCIUM
Distributed by / forMylan Pharmaceuticals Inc., Morgantown, WV 266505
NDC0378-6333-80
Show the full FDA record
Full product labelAcamprosate 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.
Recalling firmMylan Pharmaceuticals Inc
DistributionUS Nationwide.
Recall initiated2026-07-24
Report date2026-08-26
Recall completed—
Recall numberD-0774-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMorgantown WV United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.