CLASS I Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report

Ketorolac Tromethamine Injection, USP 30 mg/mL recalled

Hikma Pharmaceuticals USA is recalling Ketorolac Tromethamine Injection, USP 30 mg/mL, distributed nationwide in the US. The recall was initiated on 17 Dec 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 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

NDC0641-6041, 0641-6043, 0641-6042

Quantity recalled101,710 25 vials/shelf-pack

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0864-2020
FDA event ID: 84534
Recalling firm: Hikma Pharmaceuticals USA, Cherry Hill, NJ
Brand: Ketorolac Tromethamine
Manufacturer: Hikma Pharmaceuticals USA Inc.
Classification: Class I
Status: Terminated
Recall initiated: 17 Dec 2019
FDA classified: 2 Mar 2020
Reported: 22 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Pain Medication

Timeline

17 Dec 2019	Recall initiated by company
22 Jan 2020	Published in enforcement report	+36 days
2 Mar 2020	Classified by FDA	+40 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Product as listed by the FDA

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.

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Which lots are affected?

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

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84534

This product is part of a recall event; the main page for the event is Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020	CLASS II	Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalledKetorolac Tromethamine	Hikma Pharmaceuticals USA	Particulate Matter	Nationwide

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Other Ketorolac Tromethamine recalls

All 24

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine	Aspiro Pharma	Particulate Matter	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide