FDA Recall D-0623-2025

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 260 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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).

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

Quantity: 270,125 Vials

Reason for recall

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

Recall record

Recall number: D-0623-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: MS, OH, LA, and Puerto Rico
Recall initiated: 2025-08-27
Classified by FDA Center: 2025-09-08
FDA published: 2025-09-17
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): SUCCINYLCHOLINE CHLORIDE
Generic name(s): SUCCINYLCHOLINE CHLORIDE
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 70710-1377
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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