CVS Health Preservative Free Lubricant Eye Drops — Class II drug recall D-0389-2020
Completed recall by Altaire Pharmaceuticals, Inc., reported 2019-11-27, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0389-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Altaire Pharmaceuticals, Inc., Aquebogue, NY, United States |
| Recall initiated | 2019-07-02 |
| Classified | 2019-11-15 |
| Reported by FDA | 2019-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 77,760 units |
| Reason classes | sterility |
| Lot numbers | 02/20RCF, 03/20RCM, 03/20RDJ, 04/20RFA, 04/21, 06/20RHI, 08/19QJG, 08/20RJI, 10/19RBA, 10/20RKG, 11/20SBF, 2/21SDD |
| Model numbers | 495301 |
Product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Reason for recall
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-0389-2020. 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.