Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
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 Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Injection
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.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Ketorolac Trom 30 mg/mL Injection
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Moxi/Dex/Ketorolac 0.5%/0.1%/0.4%
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac 40mg/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
Ketorolac Trom 30 Mg/Ml Inj
Crystallization
Class II · Moderate risk
Ketorolac Tromethamine Inj. USP
Crystallization
Class II · Moderate risk
Ketorolac Tromethamine Inj. USP
Crystallization
Class II · Moderate risk
Ketorolac Trom 30 Mg/Ml Inj
Crystallization
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.