Phenylephrine Injection (Sagent) – sterility risk (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sagent Pharmaceuticals Inc
Lot Codes / Batch Numbers
Lots: PHT8IB2, PHT9IB2, exp 08/2022, PHT1JB2, exp 09/2022
Products Sold
Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
Sagent Pharmaceuticals Inc is recalling Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Sing due to Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026