Injectable hormone medication recalled for sterility assurance failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension due to lack of sterility assurance. The product was produced in a manner that cannot guarantee sterility of the injectable medication.
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 an injectable medication where sterility assurance cannot be guaranteed. No illnesses or injuries have been reported. The product qualifies as a risk-of-harm item (non-sterile injections can cause serious infection), but the absence of reported adverse events and Class II classification support High rather than Severe.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension (lot 55786) following an FDA inspection. The inspection determined the product was manufactured in a manner that cannot guarantee the sterility of this injectable medication.
Medroxyprogesterone acetate is an injectable pharmaceutical product that must be sterile. The inability to assure sterility creates a potential risk of infection from the injection.
The recalled product was distributed in Alabama, Louisiana, Mississippi, and Tennessee. The affected lot number is 55786, with a beyond-use date of December 31, 2022.
Consumers who have this medication should contact their healthcare provider to discuss whether they received a potentially affected lot and what steps to take.
The recalled product
- Product
- MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable / Hormone
- Affected units
- 40
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)
- Lot: 55786
- BUD: 12/31/2022
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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 32 products in this recall →Related recalls
Same manufacturer · Pharmacy Plus, Inc. dba Vital Care Compounder
See all →- HighCompounded Semaglutide Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-04-26
- HighAcetylcysteine eye drops recalled for sterility assurance defect
FDA (Drugs) · 2022-11-09
- HighPrescription Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- HighFDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- HighMoxifloxacin Preservative-Free Eye Drops Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22