Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Product description
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).
Lot numbers, UPCs & expiration codes
Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.
Where it was sold
MS, OH, LA, and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0623-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 27, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- 270,125 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0623-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97510
- Address
- 73 Route 31 N
- Code information
- Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.
- Postal code
- 08534-3601
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0623-2025
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 270,125 Vials
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).
- Distribution pattern
- MS, OH, LA, and Puerto Rico
- Recall initiation date
- Aug 27, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 8, 2025