Phenylephrine HCl Injection — Class II drug recall D-0305-2021
Terminated recall by Sagent Pharmaceuticals Inc, reported 2021-03-24, distributed nationwide. Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-
| Recall number | D-0305-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2021-03-11 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,716 cartons |
| Reason classes | sterility |
| NDC | 25021-0315, 25021-0315-01, 25021-0315-98, 25021-0315-99 |
| Lot numbers | PHT1JB2, PHT8IB2, PHT9IB2 |
| Expiration dates | 2022-08, 2022-09 |
Product
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Reason for recall
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
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-0305-2021. 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.