Mycophenolate Mofetil for Injection Recall Due to Precipitate
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Mylan Pharmaceuticals Inc. is recalling 5,688 vials of Mycophenolate Mofetil for Injection USP due to the presence of precipitate.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Mylan Pharmaceuticals Inc. initiated a voluntary recall of Mycophenolate Mofetil for Injection USP because of the presence of precipitate.
Which Products Are Affected
The recall affects Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, NDC 67457-386-00. Affected product is from Lot #: 3241653, Exp 4/30/2027. A total of 5,688 vials are involved in the nationwide distribution in the United States. The recall number is D-0734-2026.
What You Should Do
Consumers and healthcare providers should contact the recalling firm or their healthcare provider for further guidance on the recalled product.
Why This Matters
This Class II recall involves a prescription drug distributed nationwide that was found to contain precipitate.
Source
FDA recall D-0734-2026, Mylan Pharmaceuticals Inc., Morgantown, WV.
Original source: FDA Official Notice ↗
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