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

Yes — there is an active recall. 7 ongoing FDA recalls mention Benzocaine (36 total). Check the affected lots below.

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

Benzocaine recalls on record

none so far in 2026; 36 on record, newest first
Class III · Low risk

Dermoplast Anesthetic PAIN & ITCH

Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.

Terminated Labeling / mix-up Advantice Health D-1279-2019
Class II · Moderate risk

Finafta Baby

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Terminated cGMP deviation Product Quest Manufacturing LLC D-0079-2019
Class II · Moderate risk

Benzocaine 20%

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.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0166-2018
Class II · Moderate risk

Benzocaine 20%

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.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0165-2018
Class II · Moderate risk

Benzocaine/Menthol

Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-686-2014
Class II · Moderate risk

BENZOCAINE/MENTHOL Lozenge

Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-685-2014
Class III · Low risk

Bucalsep

Subpotent; Cetylpyridinum Chloride

Terminated Wrong potency / content Hi-Tech Pharmacal Co., Inc. NDC 58552-103-01 D-418-2013