TEARS Naturale FREE — Class II drug recall D-0666-2016
Terminated recall by Alcon Research, Ltd., reported 2016-02-24, distributed nationwide. Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solutio
| Recall number | D-0666-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2016-02-09 |
| Classified | 2016-02-16 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 12,648 cartons |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00300650416368 |
| Lot numbers | 09/17, KRJ006 |
Product
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8.
Reason for recall
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
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-0666-2016. 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.