Use cautionDrug recall · FDA · Published October 3, 2014
Sagent Recalls Ketorolac Injection Due to Labeling Errors
Sagent Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because the expiration dates on the labels are incorrect or missing.
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
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Contact the company
📍Recalling firmSagent Pharmaceuticals Inc1901 N Roselle Rd Ste 700 · Schaumburg, IL 60195-3194
✎ GovInfoNow plain-language explainer
Sagent Pharmaceuticals Inc. has recalled Ketorolac Tromethamine Injection, USP (30 mg per mL) in both 1 mL and 2 mL vials due to labeling errors. The affected products were labeled with either an incorrect expiration date or no expiration date at all. This recall affects lots MP5021, MP5024, and MP5025 distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/45738-sagent-pharmaceuticals-inc-recalls-ketorolac-tromethamine-injection-usp-30-mg.
“Sagent Recalls Ketorolac Injection Due to Labeling Errors.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45738-sagent-pharmaceuticals-inc-recalls-ketorolac-tromethamine-injection-usp-30-mg. Based on FDA recall #D-0027-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0027-2015%22&limit=1).
The FDA announced on Oct. 3, 2014, that Sagent Pharmaceuticals Inc voluntarily recalled Ketorolac Tromethamine Injection due to labeling errors showing incorrect expiration dates. The firm initiated the Class II recall affecting 69,050 vials distributed nationwide and in Puerto Rico.
How to tell if you have it
Brand: Sagent Pharmaceuticals
Product: Ketorolac Tromethamine INJECTION, USP, 30 mg per mL
1 mL vial (NDC 25021-701-01)
2 mL vial (NDC 25021-701-02)
Lot MP5021, Exp. 04/16
Lots MP5024, MP5025, Exp. 05/16
The hazard
The recall stems from labeling the product with an incorrect expiration date, according to the FDA.
Context
GovInfoNow's records show Sagent Pharmaceuticals Inc has had 10 other recalls on record since June 7, 2013. Other recent recalls of similar products include a Busulfan Injection recall (May 4, 2026), a VasoCaine Spray recall (Feb. 18, 2026), and a Levocarnitine Injection recall (April 16, 2026).
How to tell if you have this one
Check your vials for NDC numbers 25021-701-01 (1 mL vial) or 25021-701-02 (2 mL vial). Look specifically for Lot numbers MP5021, MP5024, or MP5025. Verify if the expiration date listed on the label is missing or appears incorrect.
Brand
Sagent Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Verify Lot Numbers
Check the vial labels for lot numbers MP5021, MP5024, or MP5025 and NDCs 25021-701-01 or 25021-701-02.
Contact Supplier
If you have these specific lots, contact your supplier or Sagent Pharmaceuticals for instructions on how to return or dispose of the product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide and Puerto Rico” 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.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0027-2015 (October 3, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0027-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.