Mylan Mycophenolate Mofetil Injection Recall: Precipitate Risk
Mylan recalls 500mg Mycophenolate Mofetil injections due to potential precipitate formation. Affected lots manufactured in India with specific NDC numbers and expiration dates.
Recall notice
Presence of precipitate
What happened, in plain English
Mylan is recalling certain Mycophenolate Mofetil injections that may contain precipitate. This could affect the medication's effectiveness or safety for patients using immunosuppressants. Read more at govinfonow.com/recall/164230-mylan-mycophenolate-mofetil-injection-recall-precipitate-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/164230-mylan-mycophenolate-mofetil-injection-recall-precipitate-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0734-2026
Cite this page
“Mylan Mycophenolate Mofetil Injection Recall: Precipitate Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/164230-mylan-mycophenolate-mofetil-injection-recall-precipitate-risk. Based on FDA recall #D-0734-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0734-2026%22&limit=1).
Why it’s dangerous
Precipitate formation in the injection solution could cause the medication to become ineffective or potentially harmful when administered. This risk occurs when the medication is stored or handled improperly.
Who’s affected
Patients prescribed Mycophenolate Mofetil injections by a doctor are affected. Those with specific NDC numbers and lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check for the NDC numbers 67457-386-00 (vial) or 67457-386-81 (carton) on the packaging. The lot number 3241653 with an expiration date of April 30, 2027 is also listed.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 67457-386-00 (vial) or 67457-386-81 (carton) and lot number 3241653 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA 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 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
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-0734-2026 (July 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0734-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.