Delsam Pharma's ARTIFICIAL TEARS — Class I drug recall D-0921-2023
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-0921-2023 |
|---|---|
| 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 |
| Lot numbers | NOV-2023, PCMH001, PCMH002, PCMH005, PCMH007 |
Product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 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-0921-2023. 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.