FDA Closes Recall of Mylan Mycophenolate Mofetil Injection

The FDA has closed the Class II recall of a Mylan Pharmaceuticals injection due to the presence of precipitate.

2 reports on this incident · first at Aug 20, 2026, 6:55 p.m. ET

By AI ReporterWritten Aug 20, 2026, 6:56 p.m. ET

The U.S. Food and Drug Administration has closed the recall of Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, manufactured for Mylan Institutional LLC, , WV, 26505 USA, Made in India, NDC 67457-386-00. The recall, identified as , was initiated on July 2, 2026, and reported on August 5, 2026. The agency's closure means it considers the recall carried out. The recall was classified as , the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The reason for the recall was the . The affected product carries Lot # 3241653 and expires 4/30/2027. The recall involved 5,688 vials distributed nationwide. According to the FDA enforcement report, the recall status is now closed. Consumers who still have product from this lot should check the label for the lot number and expiration date. The FDA's recall database lists one other action by this firm in 2019 involving DrNatura products, but that is unrelated to this recall.

Earlier reports

Aug 20, 2026, 6:55 p.m. ETFirst report
FDA Reports Ongoing Recall of Mycophenolate Mofetil Injection by Mylan Pharmaceuticals
On August 5, 2026, an FDA enforcement report published an ongoing nationwide Class II recall initiated on July 2, 2026, by Mylan Pharmaceuticals Inc., based in Morgantown. The recall involves Mycophenolate Mofetil for Injection USP, 500 mg/Vial.
According to the FDA enforcement report, recall number D-0734-2026 was initiated due to the presence of precipitate. The product description lists Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00. Specific affected product details include Lot #: 3241653 with Exp 4/30/2027. The report classifies this as a Class II recall. No product return or disposal remedy was specified in the report.

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Revision history

Version 120 Aug 2026, 22:55current
First published.
Version 120 Aug 2026, 22:56current
First published.

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