Phenylephrine HCI Injection — Class II drug recall D-1514-2016
Terminated recall by Sandoz Inc, reported 2016-09-28, distributed nationwide. Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product
| Recall number | D-1514-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2016-08-24 |
| Classified | 2016-09-19 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-07-12 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 66758-0016-03, 66758-0016-04, 66758-0017-01 |
Product
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Reason for recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
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-1514-2016. 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.