STERILE EYE DROPS SOOTHING TEARS — Class II drug recall D-0415-2026
Ongoing recall by K.C. Pharmaceuticals, Inc, reported 2026-04-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0415-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | K.C. Pharmaceuticals, Inc, Pomona, CA, United States |
| Recall initiated | 2026-03-03 |
| Classified | 2026-03-31 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 74,016 bottles |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00311917203003 |
| NDC | 00536-1219-94 |
| Expiration dates | 2026-09-30 |
Product
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3
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-0415-2026. 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.