Succinylcholine Injection, Solution
FDA Recall NDC 43598-666
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 (NDC 43598-666). A significant event, classified as Class II, was initiated on Sep 26, 2025 by Dr.reddy's Laboratories Inc.,. The reported reason for this action was: "Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
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
September 2025 Class II Recall: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Recall Number
Class II Ongoing
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Sep 26, 2025
Oct 15, 2025
571 vials
Recall Profile & Regulatory Data
Event ID
97690
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA.
Product Description
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
Batch or Lot Expiration Information
Lot# K250048
Affected Packages Involved in this Recall
43598-666-11Product
43598-666-25Product
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.
