FDA Recall D-0008-2026

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class II Ongoing 230 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), 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

Lot / code: Lot # K250048

Quantity: 571 vials

Reason for recall

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

Recall record

Recall number: D-0008-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA.
Recall initiated: 2025-09-26
Classified by FDA Center: 2025-10-07
FDA published: 2025-10-15
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): SUCCINYLCHOLINE
Generic name(s): SUCCINYLCHOLINE
Manufacturer(s): Dr.Reddy's Laboratories Inc.,
NDC(s): 43598-666
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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