Skip to main content
Recall Canary
Acamprosate Calcium 333 mg Tablets
← Back to all recalls
DRUG RECALLMODERATE

Acamprosate Calcium 333 mg Tablets

Mylan recalls Acamprosate Calcium 333 mg tablets over dissolution failure.

What to do

Consumers who have the affected product should stop using it and contact their pharmacist or healthcare provider for a replacement or guidance. Return the product to the place of purchase if instructed.

Recalled
Listed
Updated
Recall No.
D-0774-2026
Agency
FDA
Firm
MYLAN PHARMACEUTICALS INC
Recall ID
99483
Status
ONGOING

Why it was recalled

Mylan Pharmaceuticals is recalling Acamprosate Calcium Delayed-Release Tablets, 333 mg, 180-count bottles, because they failed dissolution specifications, which may affect drug performance.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Acamprosate Calcium, Delayed-Release Tablets

Lot code
3227809
Strength
333 mg
NDC / UPC
NDC 0378-6333-80

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Dissolution Failure recalls

Other recent recalls from MYLAN PHARMACEUTICALS INC

All recalls from MYLAN PHARMACEUTICALS INC

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification