FDA Drug recall D-0405-2025
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile,…
- FDA Drug
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile,… by Brs Analytical Services, citing cGMP deviations and lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0405-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-23 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Brs Analytical Services |
| Distribution | US |
Product
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Reason
cGMP deviations and lack of assurance of sterility.
Identifiers
| code_info | Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0405-2025%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.