Lower risk Drug recall · FDA · Published July 24, 2026

Mylan Acamprosate Tablets Recall: Failed Dissolution Specifications

Mylan recalls 333mg Acamprosate Calcium tablets due to failed dissolution specifications. This may affect medication effectiveness. Contact Mylan for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0774-2026Drug Mylan ›

Lower-risk recall

Failed Dissolution Specifications

✎ GovInfoNow plain-language explainer

Mylan is recalling 333 mg Acamprosate Calcium tablets that failed dissolution tests. This could mean the medication doesn't work properly when taken as prescribed. Read more at govinfonow.com/recall/692899-mylan-acamprosate-tablets-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/692899-mylan-acamprosate-tablets-recall-failed-dissolution-specifications · Updated September 14, 2026 · FDA enforcement record: FDA #D-0774-2026

Cite this page

“Mylan Acamprosate Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692899-mylan-acamprosate-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0774-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0774-2026%22&limit=1).

The FDA announced on July 24, 2026, that Mylan Pharmaceuticals Inc. is recalling Acamprosate Calcium Delayed-Release Tablets due to failed dissolution specifications. The recall affects 180-tablet bottles distributed nationwide.

How to tell if you have it

Brand: Mylan
Product: Acamprosate Calcium, Delayed-Release Tablets, 333 mg
Packaging: 180 tablets bottles
NDC: 0378-6333-80
Lot: 3227809
Expiry: 10/2026

The hazard

The product poses a hazard because it failed dissolution specifications. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Mylan Pharmaceuticals Inc. has 54 other recalls on record since June 28, 2012. Recent similar recalls include Teva Metoprolol Succinate Tablets Recall (Jan. 29, 2026), Lannett Niacin Extended-release Tablets Recall (May 27, 2026), and Golden State NIACIN Extended-Release Tablets Recall (May 29, 2026).

How to tell if you have this one

Check for the product name 'Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets' with NDC number 0378-6333-80. The lot number is 3227809 and it expires October 2026.

Brand
Mylan
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC number 0378-6333-80 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

Jul 24, 2026Firm started the recall
Aug 19, 2026FDA classified it Class II
Aug 26, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/692899-mylan-acamprosate-tablets-recall-failed-dissolution-specifications">Mylan Acamprosate Tablets Recall: Failed Dissolution Specifications (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0774-2026 (July 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0774-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.