Succinylcholine Chloride Injection, Solution
FDA Recall NDC 70710-1377

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Succinylcholine Chloride (NDC 70710-1377). A significant event, classified as Class II, was initiated on Aug 27, 2025 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

August 2025 Class II Recall: Failed Impurities/Degradation Specifications

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

Recall Profile & Regulatory Data

Event ID
97510
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MS, OH, LA, and Puerto Rico
Product Description
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
70710-1377-1Product
70710-1377-2Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.