Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns
Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential lack of sterility assurance due to a container defect. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Edge Pharma, LLC is recalling 5,850 syringes of Betadine (Povidone-Iodine) 5% sterile ophthalmic solution. The recall involves single-use syringes containing 0.5mL of preservative-free solution intended for topical ophthalmic use. The affected product is identified by Lot 02-2021-16@4 with a beyond-use date of 5/31/2021.
The recall was initiated due to a defective container where syringe content may migrate past the seal of the plunger. This defect may cause a lack of assurance of sterility. The product was distributed nationwide in the US.
Consumers should stop using the recalled syringes and contact Edge Pharma, LLC at 1-802-992-1178 for further instructions. The product is prescription-only and should not be injected.
The recalled product
- Product
- Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 5,850
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 02-2021-16@4 BUD 5/31/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Edge Pharma, LLC
See all →- SevereMVASI Sterile Ophthalmic Solution Lacks Assured Sterility
FDA (Drugs) · 2022-02-02
- ModerateProfound-PE Dental Gel Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
- SevereVancomycin HCl Injection Recalled for Sterility Assurance Issues
FDA (Drugs) · 2022-02-02
- ModerateCSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
- ModerateLET Topical Gel drug recall for CGMP deviations
FDA (Drugs) · 2022-02-02
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
Similar recalls
- HighBetadine Sterile Ophthalmic Solution Recalled for Sterility Assurance
FDA (Drugs) · 2022-02-02
- HighCeftazidime Sterile Ophthalmic Solution Lacks Sterility Assurance
FDA (Drugs) · 2022-02-02
- SevereEdge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2021-01-27
- SevereEdge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall
FDA (Drugs) · 2022-02-02
- SevereEpinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance
FDA (Drugs) · 2022-02-02
- SevereEye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
FDA (Drugs) · 2022-02-02