Drug Recalls

Drug Recall Results

Zicam® and Orajel™ – Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs

Date: 06/06/2025
Company: Church & Dwight Co., Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination

Amneal – Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

Date: 06/04/2025
Company: Amneal Pharmaceutical LLC
Dosage Form: Tablet
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination

UNAVY & UMOVY – Unavy Acidio Hialuronico (30 caplets/850 mg) and Umovy Acidio Hialuronico (30 caplets/850 mg)

Date: 05/22/2025
Company: UMARY USA
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: The product contains undeclared Dexamethasone, Diclofenac and Omeprazole

Endurance Boost – Dietary supplement for male performance and energy

Date: 05/06/2025
Company: EnShiShiXiangNiShangMaoYouXianGongSi
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Propoxyphenylsildenafil, Sildenafil

Amneal Pharmaceuticals LLC. – Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag

Date: 04/18/2025
Company: Amneal Pharmaceuticals LLC.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Product may contain an inert fiber identified as polypropylene fibers from the IV bag

Dr. Reddy’s – Levetiracetam in Sodium Chloride Injection

Date: 03/13/2025
Company: Dr. Reddy’s Laboratories Ltd.
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Mislabeling of infusion bag

Vitality – Vitality male enhancement dietary supplement capsules

Date: 03/03/2025
Company: One Source Nutrition
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and Tadalafil

Natural Dior LLC – Dietary Supplement

Date: 02/26/2025
Company: Natural Dior LLC
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Tadalafil

SinuCleanse – Soft Tip Squeeze Bottle Nasal Wash System

Date: 02/25/2025
Company: Ascent Consumer Products Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination of the product with Staphylococcus aureus (S. aureus)

Vitality – Vitality male enhancement dietary supplement capsules

Date: 02/20/2025
Company: One Source Nutrition
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and Tadalafil

Provepharm Inc. – Phenylephrine hydrochloride Injection, USP, 10 mg/ mL

Date: 01/24/2025
Company: Provepharm Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety – Potential Foreign Material

Astellas – Tacrolimus and Tacrolimus Extended-Release capsules

Date: 12/24/2024
Company: Astellas Pharma US, Inc.
Dosage Form: Capsule
Recall Issue Type: Other Recall Issue
Recall Reason: Bottles may contain empty capsules.

Systane – Lubricant Eye Drugs

Date: 12/23/2024
Company: Alcon Laboratories
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Due to Fungal Contamination

Par Pharmaceutical – Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)

Date: 12/20/2024
Company: Endo, Inc.
Dosage Form: Solution
Recall Issue Type: Other Recall Issue
Recall Reason: Product is an unapproved drug.

Fouzee – SugarLin Herbal Formula Herbal Dietary Supplement

Date: 12/18/2024
Company: Shoppers-Plaza
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Product contains undeclared Metformin and Glyburide

Force Forever – Dietary Supplement

Date: 12/16/2024
Company: GNMART Inc
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Product contains undeclared diclofenac and dexamethasone

Buy-herbal.com – Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules

Date: 12/13/2024
Company: Buy-herbal.com
Dosage Form: Capsule
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety – Unapproved Drug

Umary – UMARY Hyaluronic Acid tablets

Date: 11/21/2024
Company: MXBBB
Dosage Form: Tablet
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: The product contains undeclared diclofenac and omeprazole

Par Pharmaceutical – Clonazepam Orally Disintegrating Tablets, USP (C-IV)

Date: 11/19/2024
Company: Endo, Inc.
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Mislabeled with the incorrect strength on the carton

VitalityVita – Marketed as Dietary Supplement

Date: 11/06/2024
Company: VitalityVita
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and Diclofenac