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Showing 1–20 of 59 results

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ByHeart Whole Nutrition Infant Formula (ByHeart) – Botulinum Contamination (2025)

Contaminated with Clostridium botulinum

Class IVery High

FDANov 8, 2025Nationwide• ByHeart, INC.

PeriGiene Antiseptic (DermaRite Industries) – Microbial Contamination (2025)

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

FDAJul 17, 2025Nationwide• DermaRite Industries, LLC

Orajel Baby Teething Swabs (Church & Dwight) – Fungal Contamination (2025)

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

Class I

FDAJun 6, 2025Nationwide• Church & Dwight Inc

SinuCleanse Soft Tip Bottle (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

Shatavari Powder (Zaarah Herbals) – Lead Contamination (2025)

Product contains elevated levels of lead - 6.50 mg/kg (ppm)

FDAJan 27, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

Force Forever Tablets (GNMart) – Undeclared Medications (2024)

Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

FDADec 12, 2024Nationwide• GNMart LLC

Umary Acido Hialuronico (MAIN PRODUCTS) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

FDAJul 18, 2024Nationwide• MAIN PRODUCTS INC

Umary Acido Hialuronico (SoloVital) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

FDAJul 12, 2024Nationwide• SoloVital

Aloe Hand Sanitizer (Aruba Aloe) – Methanol Contamination (2024)

Chemical Contamination: Product manufactured with ethanol API that contains methanol

FDAMar 23, 2024Nationwide• Aruba Aloe Balm N.V.

Weiner Boner Honey (Pyramids) – Undeclared Drug Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

Flower Power Enhancement (Pyramids) – Undeclared Drug Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Neptune's Fix Tianeptine Elixir (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Neptune's Fix Tianeptine Elixir (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Multi-Action Relief Drops (Kilitch Healthcare) – Non-Sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

Leader Lubricant Eye Drops (Kilitch Healthcare) – non-sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

Lubricant Gel Drops (Kilitch Healthcare) – non-sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

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