Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Ketorolac recalled?

Yes — there is an active recall. 13 ongoing FDA recalls mention Ketorolac (58 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Ketorolac. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Ketorolac recalls on record

none so far in 2026; 58 on record, newest first
Class II · Moderate risk

Ketorolac Tromethamine active pharmaceutical ingredient packaged…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-743-2015
Class II · Moderate risk

Ketorolac Tromethamine INJECTION

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.

Terminated Stability / shelf life Sagent Pharmaceuticals Inc NDC 25021-701-01 D-0027-2015
Class II · Moderate risk

Ketorolac Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-376-2013
Class II · Moderate risk

Cyclopent/Ketorolac/Phenyleph/Tropicamide 1%/0.5%/2.5%/1% Ophthalmic 70 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1490-2012
Class II · Moderate risk

Ketorolac Tromethamine 30mg/Ml Injectable 10 Ml 24 Ml 500 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1552-2012