Acamprosate Calcium Tablet, Delayed Release
FDA Recall NDC 0378-6333
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acamprosate Calcium (NDC 0378-6333). A significant event, classified as Class II, was initiated on Jul 24, 2026 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Jul 24, 2026
Aug 26, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99483
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
Affected Packages Involved in this Recall
0378-6333-80Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
