CLASS III Drug recall · Reported 17 Jul 2024 · FDA Enforcement Report
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial recalled
Zydus Pharmaceuticals is recalling Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 2 Jul 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0595-2024
- FDA event ID
- 94922
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 2 Jul 2024
- FDA classified
- 10 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jul 2024 | Recall initiated by company | |
| 10 Jul 2024 | Classified by FDA | +8 days |
| 17 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products
Product as listed by the FDA
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).
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Cross contamination with other products
Which lots are affected?
Lot #: L300220, Exp. 05/31/2025.
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94922| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial recalled | Zydus Pharmaceuticals | Other | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Micafungin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial recalled | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile recalled | Xellia Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile recalled | Xellia Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalledMycamine | Astellas Pharma US | Other | Nationwide |