Phenylephrine HCl Injection (SCA) – sterility concern (2023)
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 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Brand
SCA Pharmaceuticals, LLC
Lot Codes / Batch Numbers
Lot #: 1223045282 Exp 11/24/23, 1223045370 Exp 11/26/23, 1223045624 Exp 12/07/23, 1223045723 Exp 12/10/23, 1223045732 Exp 12/10/23, 1223046128 Exp 12/24/23, 1223046133 Exp 12/24/23, 1223047112 Exp 02/02/24, 1223047232 Exp 2/07/24, 1223047398 Exp 02/15/24, 1223047456 Exp 02/16/24, 1223047569 Exp 02/18/24, 1223047694 Exp 02/24/24, 1223047780 Exp 03/07/24, 1223047859 Exp 03/08/24, 1223048119 Exp 03/20/24, 1223048183 Exp 03/22/24, 1223048837 Exp 04/18/24, 1223048838 Exp 04/18/24, 1223048982 Exp 04/24/24, 1223049144 Exp 05/02/24, 1223049145 Exp 05/02/24, 1223049147 Exp 05/02/24, 1223049821 Exp 05/30/24 Expanded Lot #: 1223048037, Exp 03/16/2024, 1223048047, Exp 03/17/2024, 1223049146, 1223049149, Exp 05/02/2024, 1223049373, Exp 05/10/2024, 1223048909, Exp 04/20/2024, 1223048696, Exp 04/12/2024, 1223050181, Exp 06/12/2024
Products Sold
Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp 02/24/24; 1223047780 Exp 03/07/24; 1223047859 Exp 03/08/24; 1223048119 Exp 03/20/24; 1223048183 Exp 03/22/24; 1223048837 Exp 04/18/24; 1223048838 Exp 04/18/24; 1223048982 Exp 04/24/24; 1223049144 Exp 05/02/24; 1223049145 Exp 05/02/24; 1223049147 Exp 05/02/24; 1223049821 Exp 05/30/24 Expanded Lot #: 1223048037, Exp 03/16/2024; 1223048047, Exp 03/17/2024; 1223049146, 1223049149, Exp 05/02/2024; 1223049373, Exp 05/10/2024; 1223048909, Exp 04/20/2024; 1223048696, Exp 04/12/2024; 1223050181, Exp 06/12/2024
SCA Pharmaceuticals, LLC is recalling PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 due to Lack of Assurance of Sterility. 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
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