Over-the-counter & supplements recalls

A&P Creations LLC Issues Nationwide Recall of X10 Natural Enhancement Supplement

Clermont, Florida – A&P Creations LLC is recalling X10 Natural Enhancement Supplement to the consumer level because it has been found to contain…

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

A&P Creations LLC Issues Nationwide Recall of biQ-FEL

Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile…

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

SUPPLX.com Issues Voluntary Nationwide Recall of Business Pill and Branch Manager for Men

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for…

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Ana Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Allies Group Inc. — THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Allies Group Inc. — THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Allies Group Inc. — THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Allies Group Inc. — THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Church & Dwight Co., Inc. — Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic

CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL)

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL)

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL)

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL)

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL)

Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL)

Lack of Assurance of Sterility

Dabur India Limited — Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes

CGMP Deviations; deficiencies observed during FDA inspection

Dabur India Limited — Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes

CGMP Deviations; deficiencies observed during FDA inspection

Dabur India Limited — Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 930

CGMP Deviations; deficiencies observed during FDA inspection