Succinylcholine injection recalled after out-of-specification degradation impurity results
Zydus Succinylcholine Chloride Injection, USP, 200 mg/10 mL, is recalled after out-of-specification test results for an individual unknown degradation impurity. 270,125 vials are affected.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an injectable medicine outside its degradation impurity specification is a potential harm and no injuries are reported.
Plain-English summary
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), in 10 mL multiple-dose sterile vials and available on prescription only, manufactured by Zydus Lifesciences Ltd in Vadodara, India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, is being recalled. Affected lots include L400077 expiring 8/31/2025, L400113 expiring 9/30/2025, L400372 and L400373 expiring 3/31/2026 and L400374. The recall covers 270,125 vials distributed in Mississippi, Ohio, Louisiana and Puerto Rico.
The recall was issued because the product failed impurities and degradation specifications, with out-of-specification test results obtained for an individual unknown degradation impurity. The FDA classified the action as Class II.
Hospitals and pharmacies holding these lots should quarantine them, stop using them, and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- SUCCINYLCHOLINE CHLORIDE (SUCCINYLCHOLINE CHLORIDE)
- Brand
- SUCCINYLCHOLINE CHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Injectable
- Affected units
- 270,125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #s: L400077
- exp: 8/31/2025
- L400113
- exp.: 9/30/2025
- L400372
- L400373
- exp.: 3/31/2026
- L400374
- exp.: 4/30/2026.
Distribution
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