Tropicamide Ophthalmic Solution USP — Class III drug recall D-0647-2016
Terminated recall by Bausch & Lomb, Inc., reported 2016-02-03, distributed nationwide. Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug
| Recall number | D-0647-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb, Inc., Tampa, FL, United States |
| Recall initiated | 2016-01-18 |
| Classified | 2016-01-28 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2020-01-06 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 24208-0585, 24208-0585-59, 24208-0585-64, 24208-0590, 24208-0590-64 |
| Lot numbers | 198821, 198901, 199961, 220111, 222281, 222291, 224841, 228281, 228291, 231531, 232601, 232671, 232681, 233471, 234901, 238861, 238931, 238941, 239781, 240331, 242341, 242351, 243351, 243391, 244931, 246171, 246341 |
| Expiration dates | 2016-01, 2016-02, 2016-03, 2016-04, 2016-06, 2016-07, 2016-08, 2016-09, 2016-11, 2017-01, 2017-02, 2017-04, 2017-05, 2017-06, 2017-07 |
Product
Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Reason for recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug 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-0647-2016. 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.