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

Yes — there is an active recall. 51 ongoing FDA recalls mention Menthol (132 total). Check the affected lots below.

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

Menthol recalls on record

none so far in 2026; 132 on record, newest first
Class II · Moderate risk

Lid O Creme

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 63788-111-25 D-1502-2019
Class II · Moderate risk

ARMY HEALTH Pain Reliever Gel With CURCUMIN

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. D-1496-2019
Class II · Moderate risk

ARMY HEALTH With CURCUMIN

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. D-1494-2019
Class II · Moderate risk

AbeeMed cream

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. D-1493-2019
Class III · Low risk

Dermoplast Anesthetic PAIN & ITCH

Labeling: Not Elsewhere Classified: Full cases may contain canisters that 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-1280-2019
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

Premier Value

Superpotent Drug: high out of specification assay results for the menthol ingredient.

Terminated Wrong potency / content Product Quest Manufacturing LLC D-0068-2019
Class II · Moderate risk

Walgreens

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

Terminated cGMP deviation Product Quest Manufacturing LLC NDC 0363-7001-01 D-0064-2019
Class II · Moderate risk

screamin' menthol

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

Terminated Chemical / undeclared Ideaz Llc D-0835-2018
Class II · Moderate risk

Zhong Hua Jiu

CGMP Deviations: the product was produced with substandard GMP manufacturing processes.

Terminated cGMP deviation United Pacific Co Ltd NDC 53614-001-02 D-0624-2018
Class II · Moderate risk

Renovo Patch

Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.

Terminated Unapproved drug TMIG Inc D-0855-2016
Class II · Moderate risk

WellPatch¿ Capsaicin Pain Relief Patch

Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section

Terminated Labeling / mix-up The Mentholatum Co. NDC 10742-8126-2 D-0018-2016
Class III · Low risk

Dr Blue Pain Relieving Gel

Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.

Terminated Wrong potency / content Indiana Botanic Gardens, Inc NDC 10578-035-05 D-1149-2015
Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1041-2014
Class II · Moderate risk

ROHTO Cooling Eye Drops

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1040-2014
Class II · Moderate risk

ROHTO Dry Eye

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1039-2014
Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1038-2014
Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1037-2014
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