Artificial Tears — Class I drug recall D-0919-2023
Ongoing recall by Global Pharma Healthcare Private Limited, reported 2023-07-19, distributed nationwide. Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
| Recall number | D-0919-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Global Pharma Healthcare Private Limited, Chennai, N/A, India |
| Recall initiated | 2023-01-30 |
| Classified | 2023-07-14 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 400,008 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 79503-0101-15 |
| Lot numbers | AUG-2024, MAR-2025, PCMI005, PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015 |
Product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Reason for recall
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
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-0919-2023. 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.