Methadone Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling methadone syringes due to lack of sterility assurance. The affected product was dispensed to patients 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 injectable drug recall for lack of sterility assurance. While no illnesses or injuries have been reported, this defect poses a real risk of contamination and infection in parenteral medications, placing it at High severity.
Plain-English summary
Sentara Infusion Services is recalling methadone syringes in 2.5MG and 4MG concentrations due to lack of sterility assurance. The affected syringes were dispensed to patients nationwide.
Lack of sterility assurance in injectable products presents a potential risk of contamination and serious infection. Patients who received these syringes should consult their healthcare provider regarding the recall and any appropriate follow-up care.
The recalled product
- Product
- METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable
- Affected units
- 19
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)
- Beyond Use Date: December 28-29
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services 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 53 products in this recall →Related recalls
Same manufacturer · Sentara Infusion Services
See all →- HighEthanol 70% Syringes Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighDaptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighFluconazole 200mg injection recalled due to sterility concerns
FDA (Drugs) · 2023-02-22
- HighMeropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighCefoxitin injectable bags recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-02-22
Same hazard · contamination risk
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Similar recalls
- HighSentara Recalls Cefazolin Due to Lack of Sterility Assurance
FDA (Drugs) · 2016-02-03
- SevereMethadone Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-02
- SevereSentara Recalls Morphine Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Ceftriaxone Infusions Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- HighInfusion Options Recalls Azacitidine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
- SevereAssurance Infusion Recalls Fentanyl Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22