Labetalol HCl Injection — Class II drug recall D-0961-2022
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2022-06-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0961-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sterile Compounding Center LLC, West Columbia, SC, United States |
| Recall initiated | 2022-05-18 |
| Classified | 2022-05-27 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2024-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 115,640 syringes |
| Reason classes | sterility |
| NDC | 69374-0946-04 |
| Lot numbers | LB1020A, LB1022A, LB2003A, LB2007A |
| Expiration dates | 2022-05-21, 2022-08-05, 2022-09-20 |
Product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Reason for recall
Lack of Assurance of Sterility
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-0961-2022. 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.