Edetate Disodium Ophthalmic Solution Recalled for Sterility Concerns
Pharmacy Innovations is recalling Edetate Disodium 1% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
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: FDA Class II recall due to sterility assurance failure from insanitary facility conditions. No illnesses or injuries reported. Per rubric, risk-of-harm products without reported injury score at High (3).
Plain-English summary
Pharmacy Innovations is recalling all lots of Edetate Disodium 1% ophthalmic solution, a prescription-only veterinary eye treatment supplied in 3 mL droptainer bottles. The product was distributed nationwide in the USA. Affected batch codes include t20221116@36, t20221005@3, t20221021@32, t20221110@60, and t20221130@10.
An FDA inspection of the manufacturer's facility in Erie, Pennsylvania discovered insanitary conditions during manufacturing that compromised the sterility assurance of this product. Ophthalmic solutions must be completely sterile to prevent serious eye infections.
No illnesses or adverse events have been reported in connection with this recall. Animal care providers and those with this product should discontinue use and contact their supplier or veterinarian for guidance on obtaining a replacement from a different manufacturer.
The recalled product
- Product
- EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
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)
- t20221116@36 t20221005@3 t20221021@32 t20221110@60 t20221130@10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations 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 59 products in this recall →Related recalls
Same manufacturer · Pharmacy Innovations
See all →- HighInjectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- HighFDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighMethylcobalamin Injectable Recall Due to Facility Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- HighInjectable vitamin B-complex products recalled for lack of sterility assurance
FDA (Drugs) · 2023-02-01
- HighDexamethasone Injectable and Ophthalmic Products Recalled for Sterility Concerns
FDA (Drugs) · 2023-02-01
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