Timolol Maleate Ophthalmic Solution — Class III drug recall D-0093-2023
Terminated recall by Apotex Corp., reported 2023-01-04, distributed nationwide. Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and
| Recall number | D-0093-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2022-12-21 |
| Classified | 2022-12-28 |
| Reported by FDA | 2023-01-04 |
| Terminated | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 22,027 bottles |
| Reason classes | specification failure |
| NDC | 60505-1005-04 |
| Lot numbers | TA4844 |
| Expiration dates | 2023-03 |
Product
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
Reason for recall
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
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-0093-2023. 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.