Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0830-2026·Announced 2026-09-09

Mylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures

Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for injection because it failed to meet dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Mylan Pharmaceuticals Inc is recalling 11,336 units of Mycophenolate Mofetil for injection, USP, 500 mg/vial. The product is distributed nationwide in the United States. The recall involves two specific lots: Lot 3242616 with an expiration date of April 2027, and Lot 8220216 with an expiration date of November 2027.

The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the expected rate when administered. Failure to meet these specifications may result in the drug not being absorbed properly by the body, potentially leading to reduced therapeutic efficacy.

Healthcare providers and patients should check their inventory for the affected NDC numbers (67457-386-00 and 67457-386-81) and lot numbers listed above. If you have this product, do not use it and contact your healthcare provider or the recalling firm for instructions on return or replacement.

The recalled product

Product: MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
Brand: MYCOPHENOLATE MOFETIL
Manufacturer: Mylan Pharmaceuticals Inc
Category: Drug — Prescription Injection
Hazard: dissolution-failure
quality-control
Affected units: 11,336

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot: 3242616
Exp. April 2027
8220216
Exp. Nov 2027

Distribution

Distributed nationwide across the United States.

Same brand · MYCOPHENOLATE MOFETIL

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Severe
Par Pharmaceutical Recalls Mycophenolate Mofetil Injection Due to Glass Fragment
FDA (Drugs) · 2019-05-15

Same manufacturer · Mylan Pharmaceuticals Inc

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