Gatifloxacin Ophthalmic Solution — Class III drug recall D-0091-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2021-11-03, distributed nationwide. Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect
| Recall number | D-0091-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2021-10-20 |
| Classified | 2021-11-02 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2022-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 16,272 bottles |
| Reason classes | potency, specification failure |
| NDC | 68180-0435-01 |
| Lot numbers | H002512 |
| Expiration dates | 2022-03-20 |
Product
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Reason for recall
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
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-0091-2022. 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.