[pending] KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Pending LLM rewrite. Source: FDA_DRUG D-0677-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch # VA0444
- exp. date 01/2026 Batch # VA4608
- exp. date 01/2026 Batch # TZ7016
UPCs (1)
- 360505100316
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · KETOROLAC TROMETHAMINE
- SevereKetorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk
FDA (Drugs) · 2025-07-02
- HighInjectable ketorolac tromethamine recalled nationwide for potential cross-contamination
FDA (Drugs) · 2022-08-24
Same category
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22