Recalls / Class II
Class IID-0008-2026
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
- Brand name
- Succinylcholine
- Generic name
- Succinylcholine
- Active ingredient
- Succinylcholine Chloride
- Route
- Intramuscular, Intravenous
- NDC
- 43598-666
- FDA application
- ANDA210698
- Affected lot / code info
- Lot # K250048
Why it was recalled
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Inc.,
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 4000, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 571 vials
- Distribution pattern
- Nationwide within the USA.
Timeline
- Recall initiated
- 2025-09-26
- FDA classified
- 2025-10-07
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0008-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.