Betadine — Class II drug recall D-0335-2021
Terminated recall by Edge Pharma, LLC, reported 2021-04-28, distributed nationwide. Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of s
| Recall number | D-0335-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edge Pharma, LLC, Colchester, VT, United States |
| Recall initiated | 2021-04-12 |
| Classified | 2021-04-19 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2022-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 5,850 syringes |
| Reason classes | sterility, packaging |
| Expiration dates | 2021-05-31 |
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 for recall
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0335-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.