Hydromorphone Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (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
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
Brand
SCA Pharmaceuticals, LLC
Lot Codes / Batch Numbers
Lot #: 1223048530, Exp 11/22/23, 1223048692 Exp 11/29/23, 1223048739 EXP 11/30/23, 1223048826 Exp 12/05/23, 1223048963 Exp 12/08/23, 1223048964 EXP 12/11/23, 1223049111 Exp 12/15/23, 1223049128 Exp12/19/23, 1223049210 EXP 12/21/23, 1223049234 Exp 12/22/23, 1223049257 Exp 12/22/23, 1223049322 Exp 12/27/23, 1223049416 Exp 12/28/23, 1223049528 Exp 01/03/24, 1223049559 Exp 01/04/24, 1223049614 Exp 01/05/24, 1223049632 Exp 01/08/24, 1223049725 Exp 01/11/24, 1223049792 Exp 01/15/24, 1223049793 Exp 01/15/24, 1223049905 Exp 01/19/24, 1223050029 Exp 1/24/24, 1223050061 Exp 01/25/24, 1223050179 Exp 01/29/24
Products Sold
Lot #: 1223048530, Exp 11/22/23; 1223048692 Exp 11/29/23; 1223048739 EXP 11/30/23; 1223048826 Exp 12/05/23; 1223048963 Exp 12/08/23; 1223048964 EXP 12/11/23; 1223049111 Exp 12/15/23; 1223049128 Exp12/19/23; 1223049210 EXP 12/21/23; 1223049234 Exp 12/22/23; 1223049257 Exp 12/22/23; 1223049322 Exp 12/27/23; 1223049416 Exp 12/28/23; 1223049528 Exp 01/03/24; 1223049559 Exp 01/04/24; 1223049614 Exp 01/05/24; 1223049632 Exp 01/08/24; 1223049725 Exp 01/11/24; 1223049792 Exp 01/15/24; 1223049793 Exp 01/15/24; 1223049905 Exp 01/19/24; 1223050029 Exp 1/24/24; 1223050061 Exp 01/25/24; 1223050179 Exp 01/29/24
SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fi 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