August 2025 FDA Recall Succinylcholine Chloride by Zydus Pharmaceuticals (usa) Inc (D-0623-2025 - Failed Impurities/Degradation Specifications)

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on August 27, 2025 for the product Succinylcholine Chloride. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in MS, OH, LA, and Puerto Rico and the recall is currently ongoing.

Recall Number: D-0623-2025

Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Initiated
08-27-2025
Reported
09-17-2025
Quantity
270,125 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97510
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS, OH, LA, and Puerto Rico
Product Description About Product Description
Full technical description of the 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).

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

70710-1377-1 Succinylcholine Chloride
70710-1377-2 Succinylcholine Chloride