Prescription Injectable Drug Recalled for Out-of-Specification Degradation Impurities
Zydus Pharmaceuticals is recalling Succinylcholine Chloride Injection due to out-of-specification test results showing unknown degradation impurities. Approximately 270,125 vials were distributed in MS, OH, LA, and Puerto Rico.
What this means for you
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: The product is an injectable medication with identified out-of-specification degradation impurities of unknown composition, meeting the criteria for a risk-of-harm product. However, no illnesses or injuries have been reported, limiting the score to High rather than higher severity levels.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Succinylcholine Chloride Injection, USP 200 mg/10 mL, a prescription medication administered intravenously or intramuscularly during anesthesia and surgical procedures.
The recall was initiated because certain lots of this injectable medication failed quality testing specifications. Test results revealed out-of-specification levels of unknown degradation impurities, indicating potential chemical contamination or degradation that does not meet regulatory standards.
Approximately 270,125 vials were distributed to healthcare facilities in Mississippi, Ohio, Louisiana, and Puerto Rico. The affected lot numbers and expiration dates are: L400077 (8/31/2025), L400113 (9/30/2025), L400372 (3/31/2026), L400373 (3/31/2026), and L400374 (4/30/2026).
As of this notice, no illnesses or adverse effects have been reported in connection with these affected vials. Patients and healthcare providers who have received or currently possess the affected medication should consult their healthcare provider for appropriate guidance.
The recalled product
- Product
- SUCCINYLCHOLINE CHLORIDE (SUCCINYLCHOLINE CHLORIDE)
- Brand
- SUCCINYLCHOLINE CHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Intravenous Injection
- Hazard
- degradation-impurity
- contamination
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
Distributed in 3 states:
- LA
- MS
- OH
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