FDA Drug recall D-0635-2020
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampu…
- FDA Drug
- Class III
- terminated
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class III recall of Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampu… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0635-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-12-13 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Identifiers
| code_info | Lot# H801686, Exp. 12/31/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0635-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.