Neostigmine Methylsulfate Injection recalled due to sterility assurance failure
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 10,700 syringes distributed nationwide.
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: This is an FDA Class II recall of an injectable drug with a sterility assurance failure, representing a significant risk of harm to patients. No illnesses or injuries have been reported, so the score is limited to 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe in pre-filled syringe packaging. The recall involves 10,700 syringes distributed nationwide in the United States.
The FDA Class II recall was initiated due to lack of assurance of sterility. This means the manufacturer cannot guarantee that the injectable product meets sterility standards required for safe use.
The affected lots are NE2004A (expiration 7/26/2022), NE2010A (expiration 9/5/2022), and NE2013A (expiration 10/20/2022). Healthcare providers and patients who have received this product should consult with their healthcare provider about potential risks and next steps. The product should not be used.
The recalled product
- Product
- Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-942-04
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance-failure
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 (6)
- Lots: NE2004A
- Exp. 7/26/2022
- NE2010A
- Exp. 9/5/2022
- NE2013A
- Exp. 10/20/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27