Over-the-counter & supplements recalls

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.

SUN PHARMA /TARO — Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5

Failed Content Uniformity Specifications.

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.

Sterling Pharmaceutical Services LLC — AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC — Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC — TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC — Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC — Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC — Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC — AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle

Lack of Assurance of Sterility

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

SHANTOU Qiwei industrial Co., Ltd — MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz

cGMP Deviations

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 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 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