Mylan recalls 500mg Mycophenolate Mofetil injections due to failed dissolution specifications. Affected lots manufactured in India with specific NDC numbers and expiration dates. Patients should contact Mylan for details.
“Mylan Mycophenolate Mofetil Injections: Failed Dissolution Specifications.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/838275-mylan-mycophenolate-mofetil-injections-failed-dissolution-specifications. Based on FDA recall #D-0830-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0830-2026%22&limit=1).
The FDA announced on Aug. 26, 2026, that Mylan Pharmaceuticals Inc. is recalling Mycophenolate Mofetil for injection due to failed dissolution specifications. The voluntary Class II recall affects 11,336 units distributed nationwide.
How to tell if you have it
Brand: Mylan
Product: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials
NDC: 67457-386-81 (Carton), 67457-386-00 (Vial)
Lot codes: 3242616 (Exp. April 2027), 8220216 (Exp. Nov 2027)
Quantity: 11,336 units
The hazard
The product failed to meet dissolution specifications, according to the FDA. The recall is classified as Class II.
Context
GovInfoNow's records show Mylan Pharmaceuticals Inc. has 54 other recalls on record since June 28, 2012. Recent Mylan recalls include a Prasugrel Tablets recall on Aug. 17, 2026, and an Acamprosate Tablets recall on July 24, 2026, both citing failed dissolution specifications. Other recent recalls of similar products include Harvard Drug Group Memantine Capsules (March 24, 2026), Teva Metoprolol Succinate Tablets (Jan. 29, 2026), and AvKARE Amantadine Capsules (Feb. 13, 2026).
How to tell if you have this one
Check the carton label for NDC 67457-386-81 (expiring April 2027) or NDC 67457-386-00 (expiring November 2027). The product is manufactured in India and sold under Mylan Institutional LLC.
Brand
Mylan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for NDC numbers 67457-386-81 or 67457-386-00 on the carton or vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. 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 14 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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-0830-2026 (August 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0830-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 16, 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.