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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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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