Moxifloxacin Ophthalmic Solution USP — Class III drug recall D-0484-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-02-20, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-
| Recall number | D-0484-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-02-01 |
| Classified | 2019-02-08 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 43,860 |
| Reason classes | specification failure |
| NDC | 68180-0422, 68180-0422-01 |
| Lot numbers | H705562, H705563, H800616 |
| Expiration dates | 2019-11, 2020-01 |
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
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-0484-2019. 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.