CLASS II Drug recall · Reported 28 Apr 2021 · FDA Enforcement Report
Betadine (Povidone-Iodine) 5% per syringe Single Use recalled
Edge Pharma is recalling Betadine (Povidone-Iodine) 5% per syringe Single Use, distributed nationwide in the US. The recall was initiated on 12 Apr 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0335-2021
- FDA event ID
- 87710
- Recalling firm
- Edge Pharma, Colchester, VT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2021
- FDA classified
- 19 Apr 2021
- Reported
- 28 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 12 Apr 2021 | Recall initiated by company | |
| 19 Apr 2021 | Classified by FDA | +7 days |
| 28 Apr 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Which lots are affected?
Lot 02-2021-16@4 BUD 5/31/2021
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Edge Pharma
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Tetracaine HCl Nasal Solution recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | CSF Otic Insufflation Capsule recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ceftazidime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |