HIGH

Zydus Lifesciences Succinylcholine Chloride Injection Recall Active for Unknown Impurity Degradation

Zydus Lifesciences recall remains active for 270,125 vials distributed across MS, OH, LA and Puerto Rico. The FDA notice cites failed impurities and degradation specifications as the reason. Immediate discontinuation is advised for healthcare providers and patients with ongoing prescriptions. Contact Zydus Pharmaceuticals USA Inc for guidance.

Quick Facts at a Glance

Recall Date
August 27, 2025
Hazard Level
HIGH
Brands
Zydus Lifesciences, Zydus Pharmaceuticals USA Inc., Succinylcholine Chloride Injection
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
3 states
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter

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About This Product

Succinylcholine Chloride Injection is a sterile, prescription neuromuscular blocker used in anesthesia. It is distributed by Zydus Pharmaceuticals USA Inc. in the U.S. Market.

Why This Is Dangerous

Out-of-Specification impurities or degradation products could compromise drug safety and patient outcomes.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Immediate discontinuation is required for affected lots to protect patient safety; financial and procedural impacts for healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Check NDCs 70710-1377-1 (vial) and 70710-1377-2 (carton).
  2. Verify lot numbers on your packaging against recall notices.
  3. Isolate affected stock and discontinue use.

Where to find product info

NDC numbers on vial label and carton; recall notification letters to healthcare facilities.

What timeline to expect

Remedy processing timelines are not specified in the notice.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or seek guidance from distributor.
  • Document all communications and stock movements.

How to prevent similar issues

  • Implement or review supplier recall procedures.
  • Use lot-level tracking and reservation of critical IV drugs.
  • Confirm FDA or manufacturer updates for remediation steps.

Documentation advice

Keep recall letters, inventory counts, and replacement records.

Product Details

Brand: Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL). Packaging: 10 mL multi-dose vials, sterile. Manufactured by Zydus Lifesciences Ltd, Vadodara, India. Distributed by Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC 70710-1377-1 (vial), 70710-1377-2 (carton). Quantity: 270,125 vials. Sold/distributed in MS, OH, LA, and Puerto Rico.

Reported Incidents

No injury or incident counts are provided in the notice.

Key Facts

  • 270,125 vials recalled
  • NDC 70710-1377-1 (vial) and 70710-1377-2 (carton)
  • Active recall as of 2025-08-27 (recall date)
  • High hazard level
View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
POISONINGELECTRICALLACERATIONOTHER

Product Classification

Product TypeIntravenous injection vial
Sold At
Multiple Retailers

Product Details

Model Numbers
L400077
L400113
L400372
L400373
L400374
UPC Codes
70710-1377
70710-1377-1
70710-1377-2
Affected States
MS, OH, LA
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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