CLASS I Drug recall · Reported 11 Jul 2018 · FDA Enforcement Report
Neostigmine Methylsulfate Injection Solution, 3 mg recalled
Fagron Compounding Services is recalling Neostigmine Methylsulfate Injection Solution, 3 mg per, 1 mg per mL prefilled syringe, 5, distributed nationwide in the US. The recall was initiated on 29 Jun 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0911-2018
- FDA event ID
- 80383
- Recalling firm
- Fagron Compounding Services, Wichita, KS
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Jun 2018
- FDA classified
- 6 Jul 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Jun 2018 | Recall initiated by company | |
| 6 Jul 2018 | Classified by FDA | +7 days |
| 11 Jul 2018 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: C274-000004678, BUD: 09/20/18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80383This product is part of a recall event; the main page for the event is Neostigmine Methylsulfate Injection Solution, 5 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Neostigmine Methylsulfate Injection Solution, 5 mg recalled | Fagron Compounding Services | Labeling Errors | Nationwide |
More recalls from Fagron Compounding Services
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin HCL added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled | Fagron Compounding Services | Sterility | Nationwide |
Other Neostigmine Methylsulfate recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | neostigmine methylsulfate 5 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 3 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 4 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |