FDA Drug recall D-0335-2021
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC…
- FDA Drug
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC… by Edge Pharma, citing defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0335-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-12 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Edge Pharma |
| Distribution | US |
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
Reason
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Identifiers
| code_info | Lot 02-2021-16@4 BUD 5/31/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0335-2021%22
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