Sagent Pharmaceuticals Inc recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent
Sagent Pharmaceuticals recalls Ketorolac injection vials due to potential microbial growth during manufacturing. This could introduce harmful bacteria into the product. Affected vials have specific NDC and lot numbers.
Lower-risk recall
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Contact the company & request your remedy
What happened, in plain English
Sagent Pharmaceuticals is recalling Ketorolac injection vials because testing found possible microbial contamination during production. This could lead to infections if the medication is used. Read more at govinfonow.com/recall/38867-sagent-ketorolac-injection-recall-microbial-growth-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38867-sagent-ketorolac-injection-recall-microbial-growth-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1274-2019
Cite this page
“Sagent Ketorolac Injection Recall: Microbial Growth Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38867-sagent-ketorolac-injection-recall-microbial-growth-risk. Based on FDA recall #D-1274-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1274-2019%22&limit=1).
Why it’s dangerous
The recall is due to microbial growth detected during a routine manufacturing simulation. This suggests the product might contain harmful bacteria, which could cause infections if injected.
Who’s affected
Prescription users of Ketorolac injection vials with NDC 25021-701-02 and lot number M813513 are affected. Healthcare providers and patients using this medication are at risk.
How to tell if you have this one
Check for vials labeled 'Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only'. The NDC number is 25021-701-02 and lot number M813513.
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Details
Look for the NDC number 25021-701-02 and lot number M813513 on the vial label.
Questions people ask
Why is this product being recalled?
Microbial growth was detected during a routine manufacturing simulation, which could mean harmful bacteria are present.
What should I do if I have this product?
The recall record does not specify a remedy, so check with your healthcare provider or Sagent Pharmaceuticals for guidance.
Is this product safe to use?
The recall indicates potential microbial contamination, so it is not safe to use without confirmation from the manufacturer.
Contact Sagent Pharmaceuticals
We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1274-2019 — Sagent Pharmaceuticals Sagent Pharmaceuticals Hello, I own a Sagent Pharmaceuticals that is covered by recall D-1274-2019 from Sagent Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-1274-2019 (April 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1274-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.