Recall archive / FDA drug enforcement
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Singl... — FDA record D-0291-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017
- Reason
- Non-Sterility
- Classification
- Class I
- Recalling firm
- Kilitch Healthcare India Limited
- Quantity
- 210,192 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0291-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide within the United States
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Nov 13, 2023
- Center classification date
- Feb 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.