Amphastar Ketorolac Injection Recall: Crystallization Risk
Amphastar recalls Ketorolac injection vials with crystallization risk. Particulate matter observed in specific lots may cause adverse reactions. Affected patients should contact pharmacy for alternatives.
Lower-risk recall
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Contact the company
What happened, in plain English
Amphastar is recalling Ketorolac Tromethamine Injection vials that may contain crystallized particles. This could lead to adverse reactions if injected. Patients should not use these vials and contact their pharmacy for alternatives. Read more at govinfonow.com/recall/41387-amphastar-ketorolac-injection-recall-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41387-amphastar-ketorolac-injection-recall-crystallization-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-1124-2017
Cite this page
“Amphastar Ketorolac Injection Recall: Crystallization Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41387-amphastar-ketorolac-injection-recall-crystallization-risk. Based on FDA recall #D-1124-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1124-2017%22&limit=1).
Why it’s dangerous
Particulate matter (crystals) in the injection may cause adverse reactions when administered. The crystallization occurs in specific batches of the medication.
Who’s affected
Patients prescribed Ketorolac injection by a doctor. Those using the recalled vial lots are most at risk.
How to tell if you have this one
Check the vial label for the product name 'Ketorolac Tromethame Injection, USP 30 mg/mL'. Look for specific lot numbers: XI002A6, XI003A6, XI004G6, XI005G6, XI007H6, XI00816, XI00916, XI01016, XI01116, XI012J6, XI013J6, XI015K6, XI016L6, XL018A7, XI019A7, XI020B7, XI021B7, XI022C7, XI023C7, XI025D7.
- Brand
Amphastar- Category
Drug
What to do — step by step
Check Vial Lot Number
Look for specific lot numbers listed in the recall notice to confirm if your vial is affected.
Contact Pharmacy
Ask your pharmacy for alternative medication options if you have the recalled vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed throughout the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I check if my vial is recalled?
Check the lot number on the vial against the list of affected lots provided in the recall notice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1124-2017 (August 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1124-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.