LEADER brand Dry Eye Relief — Class I drug recall D-0132-2024
Ongoing recall by Cardinal Health Inc., reported 2023-11-29, distributed nationwide. Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling
| Recall number | D-0132-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2023-10-31 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 21,802 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 70000-0089, 70000-0089-01 |
Product
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1
Reason for recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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-0132-2024. 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.