Bimatoprost Ophthalmic Solution 0 — Class III drug recall D-0161-2020
Terminated recall by Sandoz Inc, reported 2019-11-06, distributed nationwide. Labeling: Incorrect or missing package insert.
| Recall number | D-0161-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2019-10-17 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 346,929 bottles |
| Reason classes | labeling |
| NDC | 00781-6206, 00781-6206-75, 00781-6206-93 |
| Expiration dates | 2019-11-30, 2020-05-31, 2020-06-30, 2020-11-30, 2021-01-31, 2021-02-28, 2021-04-30, 2021-05-31 |
Product
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
Reason for recall
Labeling: Incorrect or missing package insert.
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-0161-2020. 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.