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Recall Observatory FDA recall evidence

Drug product

Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).

D-0623-2025

August 27, 2025

Class II

Product summary

Firm
Zydus Pharmaceuticals (USA) Inc
Event
Event 97510
Status
Ongoing
Classification
Class II
Quantity
270,125 Vials
Official record key
drug-enforcement:D-0623-2025

Official wording

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

Code information: Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.

Distribution pattern: MS, OH, LA, and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-Specification