Lidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.
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 pharmaceutical with no reported illnesses or injuries. The lack of sterility assurance in multi-dose injection vials represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000/mL Multi-Dose 30 mL vials (NDC 73198-0099-30) due to lack of assurance of sterility. The recall includes 310 vials with lot K41023 and beyond-use date of 5/23/2022, distributed nationwide across the USA, Puerto Rico, and US Virgin Islands.
This injectable medication is used for local anesthesia with vasoconstriction in medical and dental procedures. A failure to ensure sterility in multi-dose vials poses a potential contamination risk to patients receiving injections from affected vials.
Healthcare providers and patients who possess vials from this lot should cease use immediately and contact Olympia Compounding Pharmacy or their healthcare provider for guidance on safe disposal and alternative products. No illnesses or injuries have been reported as of the recall announcement.
The recalled product
- Product
- Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30
- Hazard
- Affected units
- 310
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 (1)
- Lot: K41023 BUD: 5/23/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy 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 · Olympia Compounding Pharmacy dba Olympia Pharmacy
See all →- HighLidocaine 2% injectable solution recalled for lack of sterility assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighCompounded pharmaceutical vials recalled due to sterility assurance failure
FDA (Drugs) · 2022-06-01
- HighOndansetron Hydrochloride vials recalled due to sterility assurance concerns
FDA (Drugs) · 2022-06-01
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