FDA Recalls Neostigmine Methylsulfate Injectable Due to Contamination Risk
Nephron Sterile Compounding Center is recalling one lot of Neostigmine Methylsulfate Injection due to potential cross-contamination from product carryover during manufacturing. The recall affects 13,500 vials distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of sterile injectable medication with potential cross-contamination. Although no illnesses have been reported, this is a risk-of-harm product where contamination could cause patient harm, meeting the rubric criterion for High severity.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection, USP, 1 mg/mL in 3 mL unit-dose vials. The recall is due to potential cross-contamination from product carryover during manufacturing, which is a deviation from Good Manufacturing Practice (CGMP) requirements.
The affected lot is NE1057A, which expires 10/23/2022. A total of 13,500 vials were distributed nationwide in the United States. The product is a prescription medication supplied as a sterile injectable.
Those who may have received this product should verify the lot number and contact their healthcare provider or supplier for guidance regarding the recall.
The recalled product
- Product
- PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Affected units
- 13,500
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 (2)
- Lot: NE1057A
- Exp. 10/23/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Nephron Sterile Compounding Center LLC
See all →- HighSodium Chloride Injection Recalled for Potential Sterility Compromise
FDA (Drugs) · 2025-03-19
- HighNorepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighNephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighDiltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
- HighFDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- ModerateNeostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls
FDA (Drugs) · 2022-11-23
- HighNeostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27
- HighNeostigmine Methylsulfate Injection recalled due to sterility assurance failure
FDA (Drugs) · 2022-07-27
- HighNeostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27
- HighPhenylephrine injection lacks sterility assurance; FDA recalls vials
FDA (Drugs) · 2023-03-08
- HighMorphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27