Methylprednisolone steroid injections recalled for lack of sterility assurance
Sentara Infusion Services is recalling 27 syringes of Methylprednisolone steroid due to lack of sterility assurance. The product was distributed nationwide to patients with a beyond-use date of December 29-31, 2022.
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: The FDA classified this as a Class II recall with no reported illnesses or injuries. However, sterility failure on an injectable medication represents a significant risk of harm to patients, placing this in the High (Score 3) category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling 27 syringes of Methylprednisolone 12MG in normal saline, a corticosteroid medication, that were dispensed to patients nationwide. The syringes were prepared and distributed by Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia.
The recall was initiated due to a lack of sterility assurance on the product. Sterility is critical for injectable medications.
The affected syringes have a beyond-use date of December 29-31, 2022. If you have received this medication, contact your healthcare provider or pharmacist to confirm whether you were affected and to discuss any appropriate follow-up.
The recalled product
- Product
- Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 27
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 29-31
- 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
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereSentara Recalls Solumedrol Bags Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-02-03
- HighMethotrexate Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-02-02
- HighSentara Recalls Cefazolin Due to Lack of Sterility Assurance
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Ascorbic Acid Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- Severe
- SevereMethylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance
FDA (Drugs) · 2022-01-19