FDA DrugsClass II
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene gly...
Published: April 8, 2026Recall ID: D-0415-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Pomona |
| State | CA |
| Event id | 98533 |
| Address 1 | 3420 Pomona Blvd |
| Code info | Lot: a) SY24K01, SY24K02, Exp.: 09/30/26; b) SY24K01, SY24K02, Exp.: 09/30/26. |
| Postal code | 91768-3236 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 74,016 bottles |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | |
| Center classification date | 20260331 |
Overview
- Recalling FirmK.C. Pharmaceuticals, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the US