September 2025 FDA Recall Succinylcholine by Dr. Reddy's Laboratories, Inc. (D-0008-2026 - Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.)

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on September 26, 2025 for the product Succinylcholine. The FDA reported the reason for recall as out-of-specification (oos) result during the 6-month stability testing; decreased preservative concentration.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0008-2026

Reason for Recall
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Initiated
09-26-2025
Reported
10-15-2025
Quantity
571 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97690
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.
Dr. Reddy's Laboratories, 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.
Nationwide within the USA.
Product Description About Product Description
Full technical description of the product.
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

43598-666-11 Succinylcholine
43598-666-25 Succinylcholine