Bimatoprost Ophthalmic Solution — Class III drug recall D-0635-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-01-08, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual imp
| Recall number | D-0635-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-12-13 |
| Classified | 2020-01-02 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2020-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,130 bottles |
| Reason classes | specification failure |
| NDC | 68180-0429-03 |
| Lot numbers | H801686 |
| Expiration dates | 2019-12-31 |
Product
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
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-0635-2020. 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.