Micafungin for injection recall
FDA recall D-0596-2024 · initiated Jul 2, 2024
Zydus Pharmaceuticals (USA) Inc recalled Micafungin for injection in Jul 2024 — an FDA Class III recall (D-0596-2024) because Cross contamination with other products.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross contamination with other products
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: n/a
Details
- Product
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
- Recalling company
- Zydus Pharms
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Jul 2, 2024
- FDA report date
- Jul 17, 2024
Frequently asked
- Was Micafungin for injection recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Micafungin for injection in Jul 2024 — an FDA Class III recall (D-0596-2024) because Cross contamination with other products. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Micafungin for injection recalled?
- Per the FDA enforcement record, the reason for recall D-0596-2024 was: Cross contamination with other products
- Is a recalled Micafungin for injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Micafungin for injection are affected?
- Distributed: Nationwide in the USA and Puerto Rico. The recall covers these lots — Lot #: L300217, Exp. 04/31/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0596-2024.