Mylan Recalls Mycophenolic Acid Tablets Due to Dissolution Failure
Mylan Lab Inc recalls specific lots of Mycophenolic Acid Delayed-release Tablets because they failed dissolution specifications. Check your bottle's lot number.
Use caution until it’s fixed
Failed Dissolution Specifications: Low out of specification dissolution results.
Contact the company
What happened, in plain English
Mylan Lab Inc is recalling a specific batch of Mycophenolic Acid Delayed-release Tablets, 180 mg, in 120-count bottles. The recall was issued because the tablets did not meet dissolution specifications, meaning they may not release the medication properly. This could affect how well the drug works for patients who rely on it. Read more at govinfonow.com/recall/44675-mylan-lab-inc-recalls-mycophenolic-acid-delayed-release-tablets-180.
Source Summary by GovInfoNow · govinfonow.com/recall/44675-mylan-lab-inc-recalls-mycophenolic-acid-delayed-release-tablets-180 · Updated October 12, 2026 · FDA enforcement record: FDA #D-1111-2015
Cite this page
“Mylan Recalls Mycophenolic Acid Tablets Due to Dissolution Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44675-mylan-lab-inc-recalls-mycophenolic-acid-delayed-release-tablets-180. Based on FDA recall #D-1111-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1111-2015%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, resulting in low out-of-specification dissolution results. This means the medication might not dissolve or release as intended, potentially leading to ineffective treatment for the condition it is prescribed to treat.
Who’s affected
Patients currently taking Mycophenolic Acid Delayed-release Tablets, 180 mg, from the recalled lot are affected. Individuals who purchased these specific bottles nationwide prior to May 20, 2015, may have the product.
How to tell if you have this one
Check your bottle for NDC 0378-4201-78 and UPC 3 0378-4201-78 7. The recalled lot number is 3059043 with an expiration date of 08/16. The product contains 180 mg tablets in a 120-count bottle.
- Brand
Mylan- Product
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches NDC 0378-4201-78, UPC 3 0378-4201-78 7, Lot # 3059043, and Exp 08/16.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on how to proceed.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1111-2015 (May 20, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1111-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.