Ketorolac Tromethamine Injection recall
FDA recall D-0036-2026 · initiated Oct 1, 2025
Aspiro Pharma Limited recalled Ketorolac Tromethamine Injection in Oct 2025 — an FDA Class II recall (D-0036-2026) because Presence of Particulate Matter: Particulate matter identified as glass.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as glass
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
- Recalling company
- Aspiro
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Oct 1, 2025
- FDA report date
- Oct 29, 2025
Frequently asked
- Was Ketorolac Tromethamine Injection recalled?
- Aspiro Pharma Limited recalled Ketorolac Tromethamine Injection in Oct 2025 — an FDA Class II recall (D-0036-2026) because Presence of Particulate Matter: Particulate matter identified as glass. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ketorolac Tromethamine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0036-2026 was: Presence of Particulate Matter: Particulate matter identified as glass
- Is a recalled Ketorolac Tromethamine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ketorolac Tromethamine Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0036-2026.