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Showing 21–40 of 56 results

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ChloraPrep Applicators (CareFusion) – Contamination Risk (2025)

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

FDAFeb 14, 2025Nationwide• CareFusion 213, LLC

SinuCleanse Neti Pot (Ascent) – Bacterial Contamination (2025)

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

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

SinuCleanse Saline Packets (Ascent) – Bacterial Contamination (2025)

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

Class IHigh

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

Systane Eye Drops (Alcon) – non-sterility concern (2024)

Non-Sterility

FDADec 18, 2024Nationwide• Alcon Research LLC

Cajun Sesame Hot Sticks (Cal Yee) – undeclared allergens (2024)

Undeclared Gluten

Undeclared wheat, Undeclared soybean oil

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

New Orleans Hot Mix (Cal Yee) – undeclared allergens (2024)

Undeclared Gluten

Undeclared wheat, Undeclared soybean oil

FDADec 6, 2024AZ, CA, NM +6 more• Cal Yee Farm LLC

Suntegrity Sunscreen (Synchronicity) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

FDAMay 24, 2024Nationwide• SYNCHRONICITY SPA INC, DBA SUNTE

Aahu Barah Apricot Roll (Global Commodities) – Elevated Sulfites (2024)

Undeclared Allergen

Product contains elevated levels of undeclared sulfites.

FDAMay 10, 2024MD, MO, NY +3 more• Global Commodities Inc

GoHARD 25000 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.

Pink Pussycat 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.

Samurai-X 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.

GOAT Sublingual Strip (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.

Silverback XXX Power Enhancer (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.

Honey Manuka Bunny Love (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.

Alphastrip Performance Enhancer (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 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

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

Tejocote Root 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

Tejocote Root 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

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