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Over-the-Counter

💊 Drugs • 320 recalls

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. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Over-the-Counter View Details →

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. NDC: 35192-052-18, UPC 8 18204 02513 8

CA BOTANA International

Class I - Dangerous

CGMP Deviations

Oct 10, 2025 Over-the-Counter View Details →

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

Church & Dwight

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

Jun 6, 2025 Over-the-Counter Nationwide View Details →

Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Over-the-Counter View Details →

KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Over-the-Counter View Details →

Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81

LNK International

Class I - Dangerous

CGMP Deviations: Released product should have been rejected.

Nov 14, 2024 Over-the-Counter Nationwide View Details →

THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1

Unexo Life Sciences Private Limited

Class I - Dangerous

cGMP Deviations

Oct 24, 2024 Over-the-Counter Nationwide View Details →

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031

Unexo Life Sciences Private Limited

Class I - Dangerous

cGMP Deviations

Oct 24, 2024 Over-the-Counter Nationwide View Details →

LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105

Unexo Life Sciences Private Limited

Class I - Dangerous

cGMP Deviations

Oct 24, 2024 Over-the-Counter Nationwide View Details →

JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5

Unexo Life Sciences Private Limited

Class I - Dangerous

cGMP Deviations

Oct 24, 2024 Over-the-Counter Nationwide View Details →

Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05

JR Watkins

Class I - Dangerous

cGMP Deviations

Nov 1, 2024 Over-the-Counter Nationwide View Details →

CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9

Unexo Life Sciences Private Limited

Class I - Dangerous

cGMP Deviations

Oct 24, 2024 Over-the-Counter Nationwide View Details →

HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6

Unexo Life Sciences Private Limited

Class I - Dangerous

cGMP Deviations

Oct 24, 2024 Over-the-Counter Nationwide View Details →

Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5

GLOBAL WIDGET

Class I - Dangerous

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

Jun 25, 2024 Over-the-Counter Nationwide View Details →

Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44

Global

Class I - Dangerous

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Feb 16, 2024 Over-the-Counter Nationwide View Details →

TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.

Optikem International

Class I - Dangerous

Lack of Assurance of Sterility

Feb 29, 2024 Over-the-Counter Nationwide View Details →

Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12

Global

Class I - Dangerous

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Feb 16, 2024 Over-the-Counter Nationwide View Details →

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

OMEZA

Class I - Dangerous

CGMP Deviations

Jan 19, 2024 Over-the-Counter Nationwide View Details →

Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

Dollar Tree Distribution

Class I - Dangerous

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

Oct 5, 2023 Over-the-Counter Nationwide View Details →

TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.

AMMAN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Lack of Assurance of Sterility

Sep 1, 2023 Over-the-Counter View Details →

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