Phenylephrine HCl Injection — Class II drug recall D-0359-2023
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2023-03-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0359-2023 |
|---|---|
| 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 | 2023-02-22 |
| Classified | 2023-02-27 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 546,450 vials |
| Reason classes | sterility |
| NDC | 69374-0302-10 |
| Lot numbers | PE2025, PE2026, PE2027, PE2030, PE2031, PE2032, PE2032A, PE2033, PE2034, PE2035 |
| Expiration dates | 2023-05-28, 2023-06-02, 2023-06-04, 2023-06-27, 2023-06-29, 2023-07-09, 2023-08-03, 2023-08-31, 2023-09-11 |
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.
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-0359-2023. 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.