FDA Issues Class II Recall of Zydus Succinylcholine Chloride Injection Over Impurity Concerns

The US Food and Drug Administration (FDA) has posted a Class II recall involving Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), supplied in 10 mL multiple-dose vials. The product, manufactured by Zydus Lifesciences Ltd in Vadodara, India, and distributed in the US by Zydus Pharmaceuticals Inc, is labeled for prescription use only. This recall affects 270 125 vials across multiple lots (L400077, L400113, L400372, L400373, and L400374) with expiration dates spanning from August 2025 through April 2026. Distribution was limited to Mississippi, Ohio, Louisiana, and Puerto Rico.

The recall was initiated after the company identified out-of-specification test results tied to unknown degradation impurities. Such deviations in chemical stability could impact drug purity and patient safety. The FDA classified the action as a Class II recall, indicating that the product’s use may cause temporary or medically reversible adverse health consequences, but the probability of serious harm is remote. The recall was initiated voluntarily by Zydus Pharmaceuticals (USA) Inc on August 27, 2025, with the FDA formally classifying it on September 8, 2025. Notifications to consignees were made through letters, and as of now, the recall remains ongoing without a press release issued.

Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker primarily indicated for use as an adjunct to general anesthesia. It provides skeletal muscle relaxation during surgical procedures and facilitates endotracheal intubation or mechanical ventilation. Pharmacists and health care providers should review their inventories for the affected lots and ensure proper quarantine and return procedures, while also remaining vigilant for patient safety communications given the clinical importance of this medication in critical care and surgical settings.