L-Cysteine Hydrochloride Injection (Sandoz Inc) – Sterility Risk (2016)
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
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Brand
Sandoz Inc
Lot Codes / Batch Numbers
Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17, 2092315, 2093015, Exp 09/17, 2100115, Exp 10/17, 2120115, 2120215, Exp 12/17
Products Sold
Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17; 2100115, Exp 10/17; 2120115, 2120215, Exp 12/17
Sandoz Inc is recalling L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005- due to Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.. 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: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
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