# FDA recall D-0335-2021

> **Edge Pharma, LLC** · Class II · drug recall initiated 2021-04-12.

## 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

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0335-2021
- **Recalling firm:** Edge Pharma, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-12
- **Report date:** 2021-04-28
- **Termination date:** 2022-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colchester, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2021

## Citation

> AI Analytics. FDA recall D-0335-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-0335-2021. Source: US FDA. Licensed CC0.

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