FDA Recalls Neostigmine Injectable Syringes Due to Sterility Assurance Deficiency
FDA is recalling Central Admixture Pharmacy Services' neostigmine injectable syringes due to lacking validation data for sterilization decontamination cycles, raising concerns about product sterility.
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 a sterile injectable medication with inadequate sterilization validation. Although no illnesses or injuries have been reported, the lack of sterility assurance in an injectable product represents a significant potential for harm.
Plain-English summary
Central Admixture Pharmacy Services is recalling 6,468 neostigmine 5 mg/5mL syringes nationwide due to inadequate validation of the sterilization decontamination process used during drug preparation.
The manufacturer lacks validation data confirming that its decontamination cycles effectively ensure the sterility of the finished product. This deficiency means there is no assurance that the syringes are adequately sterilized, creating a potential contamination risk.
Healthcare facilities and providers who have received affected lots should identify them using the provided lot numbers and expiration dates, and stop using them immediately. They should contact Central Admixture Pharmacy Services or their distributor for return or replacement instructions.
Patients who have been administered doses from affected lots should consult their healthcare provider if they experience signs of infection.
The recalled product
- Product
- neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- sterility-assurance
- contamination-risk
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 (20)
- Lot: 36-239285
- 36-239287
- Exp. 7/11/2023
- 36-239456
- Exp. 7/12/2023
- 36-239873
- Exp. 7/13/2023
- 36-240994
- 36-240995
- 36-240996
- 36-240997
- Exp. 7/18/2023
- 36-241447
- Exp. 7/20/2023
- 36-242407
- 36-242408
- Exp. 7/25/2023
- 36-246298
- Exp. 8/3/2023
- 36-248998
Distribution
Distributed nationwide across the United States.
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