FDA Drug recall D-0835-2026
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705…
- FDA Drug
- Class III
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class III recall of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705… by Imprimisrx Nj, citing subpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0835-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-24 |
| Published | 2026-09-16 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Imprimisrx Nj |
| Distribution | US |
Product
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
Reason
Subpotent Drug
Identifiers
| code_info | Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Imprimisrx Nj
- Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ
FDA Drug · Class II · 2022-11-23 · Imprimisrx Nj - Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West…
FDA Drug · Class II · 2019-08-07 · Imprimisrx Nj - Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewo…
FDA Drug · Class II · 2019-08-07 · Imprimisrx Nj
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0835-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.