Succinylcholine Chloride Injection recall
FDA recall D-0623-2025 · initiated Aug 27, 2025
Zydus Pharmaceuticals (USA) Inc recalled Succinylcholine Chloride Injection in Aug 2025 — an FDA Class II recall (D-0623-2025) because Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 270,125 Vials
Details
- Product
- 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).
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MS, OH, LA, and Puerto Rico
- Initiated
- Aug 27, 2025
- FDA report date
- Sep 17, 2025
Frequently asked
- Was Succinylcholine Chloride Injection recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Succinylcholine Chloride Injection in Aug 2025 — an FDA Class II recall (D-0623-2025) because Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Succinylcholine Chloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0623-2025 was: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- Is a recalled Succinylcholine Chloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Succinylcholine Chloride Injection are affected?
- Distributed: MS, OH, LA, and Puerto Rico. The recall covers these lots — Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0623-2025.