Bimatoprost Ophthalmic Solution 0 — Class III drug recall D-0429-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-02-13, distributed nationwide. Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total
| Recall number | D-0429-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-01-28 |
| Classified | 2019-02-05 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2020-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 9,930 bottles |
| Reason classes | specification failure |
| NDC | 68180-0429-02, 68180-0429-03 |
| Expiration dates | 2020-03, 2020-04, 2020-05, 2020-06, 2020-08 |
Product
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
Reason for recall
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
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-0429-2019. 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.