Daptomycin for Injection 350 mg/vial 1 Single-dose vial — Class I drug recall D-0131-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-01-25, distributed nationwide. Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per
| Recall number | D-0131-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2022-11-29 |
| Classified | 2023-01-13 |
| Reported by FDA | 2023-01-25 |
| Terminated | 2024-02-22 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 16729-0434-05 |
| Lot numbers | R2200232 |
| Expiration dates | 2025-01 |
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Reason for recall
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
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-0131-2023. 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.