Lotemax — Class III drug recall D-1396-2019
Terminated recall by Bausch & Lomb, reported 2019-06-19, distributed nationwide. Failed Stability Specifications: Out of specification for viscosity.
| Recall number | D-1396-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb, Tampa, FL, United States |
| Recall initiated | 2019-06-17 |
| Classified | 2019-06-19 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2021-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 170,832 bottles |
| Reason classes | specification failure |
| NDC | 24208-0503, 24208-0503-07, 24208-0503-48, 24208-0503-96 |
| Lot numbers | 282611, 282971, 282981, 283431, 283441, 283451, 283611, 283621, 283631 |
| Expiration dates | 2019-10, 2019-11 |
Product
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Reason for recall
Failed Stability Specifications: Out of specification for viscosity.
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-1396-2019. 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.