Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL Injection
Lack of Assurance of Sterility
Is Neostigmine recalled?
Not under an active recall.
Neostigmine was recalled 30 times in the past — all now closed. Most recent: Nov 9, 2023.
Most common reason: Sterility / contamination (19 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Neostigmine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Neostigmine recalls on record
none so far in 2026; 30 on record, newest first
Class II · Moderate risk
neostigmine 5 mg/5mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine methylsulfate
Lack of Assurance of Sterility
Class II · Moderate risk
neostigmine methylsulfate 5 mg/5 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class III · Low risk
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Labelling: Missing label.
Class II · Moderate risk
NEOstigmine Methylsulfate
Lack of Assurance of Sterility
Class II · Moderate risk
NEOstigmine Methylsulfate
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methyl Sulfate 1mg/Ml Inj Sol Syr
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Lack of Assurance of Sterility
Class I · High risk
Neostigmine Methylsulfate Injection Solution
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class I · High risk
Neostigmine Methylsulfate Injection Solution
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class II · Moderate risk
NEOstigmine Methylsulfate
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Class II · Moderate risk
Neostigmine Methylsulfate Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Neostigmine Methylsulfate 5 mg/5 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
Neostigmine Methylsulfate
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Neostigmine Methylsulfate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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