Amphotericin B Liposome for Injection — Class II drug recall D-0493-2024
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2024-05-15, distributed nationwide. Out of specification for assay
| Recall number | D-0493-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2024-04-19 |
| Classified | 2024-05-08 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 11,016 vials |
| Reason classes | potency, specification failure |
| NDC | 62756-0233, 62756-0233-01, 62756-0233-02 |
| Lot numbers | BAE0055A, BAE0056A, BAE0068A |
| Expiration dates | 2026-03 |
Product
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
Reason for recall
Out of specification for assay
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0493-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.