Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25
Hikma Pharmaceuticals recalls Ketorolac injection vials with polydimethylsiloxane particles. Stop using if you have these specific vials. No remedy provided in official notice.
Stop using this now
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Contact the company & request your remedy
What happened, in plain English
Hikma Pharmaceuticals is recalling Ketorolac injection vials that contain particles of polydimethylsiloxane (PDMS). This could cause serious injury if injected. The recall affects specific vial packaging and expiration dates. Read more at govinfonow.com/recall/37643-hikma-ketorolac-injection-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37643-hikma-ketorolac-injection-recall-particulate-matter-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0658-2020
Cite this page
“Hikma Ketorolac Injection Recall: Particulate Matter Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37643-hikma-ketorolac-injection-recall-particulate-matter-risk. Based on FDA recall #D-0658-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0658-2020%22&limit=1).
Why it’s dangerous
Particles of polydimethylsiloxane (PDMS) can be injected into the body, potentially causing serious injury. This is a known risk with particulate matter in injectable medications.
Who’s affected
Patients prescribed Ketorolac injection by a doctor who have the specific vial packaging (NDC 0641-6043-01) and expiration dates listed. Those with the vials may face serious injury if the particles are injected.
How to tell if you have this one
Check for vials labeled 'Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL)' with NDC 0641-6043-01. The vials were sold in 25-pack shelf packs with specific expiration dates: March 2020, May 2020, July 2020, and November 2020.
- Brand
Hikma Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide within the United States- NDC
0641-6043-01, 0641-6043-25, 0641-6042-01, 0641-6042-25, 0641-6041-01, 0641-6041-25
| Recall number | Product, codes & lots | Quantity | Class |
|---|---|---|---|
| D-0658-2020 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.; 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020 | 25,817 shelf packs/25 vials per pack | Class II |
| D-0864-2020 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.; Lot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021 | 101,710 25 vials/shelf-pack | Class I |
What to do — step by step
Stop Using Now
Immediately stop using any vials with the NDC 0641-6043-01 packaging if you have them.
Questions people ask
Is there a fix for this recall?
The official notice does not provide a remedy for this recall.
What is the specific product being recalled?
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL) in 2 mL Single Dose Vials (NDC 0641-6043-01).
How can I tell if I have the recalled product?
Look for vials with NDC 0641-6043-01 and expiration dates of March 2020, May 2020, July 2020, or November 2020.
Contact Hikma Pharmaceuticals
We’ve drafted a message you can send Hikma Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0658-2020 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-0658-2020 from Hikma 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.
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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-0658-2020 (December 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0658-2020 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.