Ketorolac Tromethamine Ophthalmic Solution — Class II drug recall D-0677-2025
Ongoing recall by Apotex Corp., reported 2025-10-08, distributed nationwide. Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential steri
| Recall number | D-0677-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2025-09-05 |
| Classified | 2025-09-30 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 493,468 bottles |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00360505100316 |
| NDC | 60505-1003, 60505-1003-01, 60505-1003-02 |
| Lot numbers | TZ7016, VA0444, VA4608 |
| Expiration dates | 2025-12, 2026-01 |
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Reason for recall
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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-0677-2025. 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.