Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each…
Reason Lack of Assurance of Sterility
Is Menthol recalled?
131 FDA recalls mention Menthol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Menthol.
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M…
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D…
Reason CGMP Deviations
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