Mycophenolate Mofetil Recalled Due to the Presence of Precipitate

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for mycophenolate mofetil, 500 mg. The affected batch has been identified as Lot 3241653 (expires April 2027), affecting 5688 vials.
• The recall was initiated by Mylan Pharmaceuticals, Inc due to the presence of precipitate, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Mycophenolate mofetil is used to suppress the body’s immune system for patients receiving kidney, heart, or liver transplants.

The FDA has issued a Class II recall for mycophenolate mofetil, 500 mg, affecting 5688 vials. This product is being recalled by Mylan Pharmaceuticals, Inc based in Morgantown, West Virginia. The recall was initiated on July 2, 2026, and received a Class II classification on August 4, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the presence of precipitate in the product. This deficiency affects Lot 3241653, which will expire in April 2027. Mylan Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

Mycophenolate mofetil is used to weaken the body’s immune system to prevent organ transplant rejection in patients with kidney, heart, or liver transplants. Pharmacists should identify and quarantine Lot 3241653, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 5, 2026. Accessed August 5, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221411