Micafungin injection vials recalled for cross-contamination
Zydus Pharmaceuticals is recalling Micafungin for injection (100 mg/vial, Lot #L300220) due to potential cross-contamination with other products. Approximately 12,720 vials distributed nationwide in the USA and Puerto Rico are affected.
What this means for you
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: This is an FDA Class III recall with no reported illnesses or injuries. The source does not identify specific contaminants, making the cross-contamination hazard theoretical. FDA Class III recalls are typically assigned scores of 1 or 2; the lack of reported harm supports a Moderate classification.
Plain-English summary
Micafungin for injection, USP, 100 mg/vial is being recalled by Zydus Pharmaceuticals (USA) Inc. The affected lot is #L300220 with expiration 05/31/2025, involving approximately 12,720 vials distributed nationwide in the USA and Puerto Rico.
The recall is initiated due to potential cross-contamination with other products. The FDA has classified this as a Class III recall.
The recalled product
- Product
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Antifungal injection
- Hazard
- Affected units
- 12,720
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 (2)
- Lot #: L300220
- Exp. 05/31/2025.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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