Artificial Tears Ophthalmic Solution — Class II drug recall D-0404-2025
Ongoing recall by BRS Analytical Services, LLC, reported 2025-05-14, distributed nationwide. cGMP deviations and lack of assurance of sterility.
| Recall number | D-0404-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BRS Analytical Services, LLC, Saint Louis, MO, United States |
| Recall initiated | 2025-04-23 |
| Classified | 2025-05-06 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, cgmp |
| NDC | 50268-0043, 50268-0043-15 |
| Lot numbers | 126, 127, 128, 129, 162, 163, 164, 165, 166, 167, 168, 169, 170, 193, 194, 195, 196, 197, 198, 199 |
| Expiration dates | 2025-10-26, 2025-10-30, 2025-11-02, 2025-11-06, 2026-05-09, 2026-05-14, 2026-05-20, 2026-05-23, 2026-05-29, 2026-06-03, 2026-06-06, 2026-06-10, 2026-06-13, 2026-10-07, 2026-10-10, 2026-10-14, 2026-10-17, 2026-10-21, 2026-10-24, 2026-10-30 |
Product
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
Reason for recall
cGMP deviations and 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-0404-2025. 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.