Gatifloxacin Ophthalmic Solution 0 — Class III drug recall D-1490-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-07-24, distributed nationwide. Labeling: Missing label; Product complaints reported missing bottle label.
| Recall number | D-1490-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-07-11 |
| Classified | 2019-07-17 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 17,238 bottles |
| Reason classes | labeling |
| NDC | 68180-0435-01 |
| Lot numbers | H805157 |
| Expiration dates | 2020-05 |
Product
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
Reason for recall
Labeling: Missing label; Product complaints reported missing bottle label.
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-1490-2019. 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.