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Fresenius Kabi Compounding, LLC

Fresenius Kabi Compounding, LLC Recalls

All product recalls associated with Fresenius Kabi Compounding, LLC.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1781–1800 of 25000 recalls

Thiamine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

cGMP violations

Class IIModerate

FDASep 25, 2024Nationwide• Fresenius Kabi Compounding, LLC

Adult Cough Medicine (Denison) – Crystallization Issue (2024)

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Class IIILow

FDASep 25, 2024Nationwide• Denison Pharmaceuticals, LLC

Kids Cough Medicine (Denison) – Crystallization Issue (2024)

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Class III

1...88 899091 92...1250

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Low

FDASep 25, 2024Nationwide• Denison Pharmaceuticals, LLC

Aston Martin DBX707 (Aston Martin) – Oil Cooler Hose (2024)

Fire/Burn Risk

Aston Martin The Americas (Aston Martin) is recalling certain 2024-2025 DBX707, 2024-2025 DB12, and 2025 Vantage vehicles. The engine oil cooler hose may split during vehicle operation, resulting in a loss of oil and oil pressure.

High

NHTSASep 24, 2024Nationwide• ASTON MARTIN

Quest Spectrum 3 System (Olympus) – EMC Compliance (2024)

Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention

Moderate

FDASep 24, 2024OH• Olympus Corporation of the Americas

Vial2Bag Advanced (West Pharmaceutical) – Packaging Damage (2024)

Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.

Moderate

FDASep 24, 2024AL, AZ, AR +30 more• West Pharmaceutical Services AZ, Inc.

Grabeez Big Cheese Snack Mix (Tropical Nut) – Undeclared Nuts (2024)

Undeclared Allergen

Undeclared Almonds & Cashews. The firm was notified by their customers that the product contains a trail mix instead of the cheese mix. The trail mix contains almonds and cashews that are not listed in the ingredient statement.

Class IIModerate

FDASep 24, 2024FL, GA, IL +9 more• Tropical Nut & Fruit Company

Dapsone Gel (Viona) – Crystallization Problem (2024)

Crystallization

Class IIModerate

FDASep 24, 2024NY• VIONA PHARMACEUTICALS INC

Atorvastatin Tablets (Nivagen) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Class IIModerate

FDASep 24, 2024Nationwide• Nivagen Pharmaceuticals Inc

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Defective Delivery System: The dip tube is clogged causing the spray not to work.

Class IIModerate

FDASep 24, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Sour Charlie Bread (Salt City Baking) – Undeclared Wheat (2024)

Undeclared Gluten

Undeclared Wheat flour. Product contains wheat flour but product was sold without the Ingredients Statement.

Class IIModerate

FDASep 23, 2024IN, UT• Salt City Baking Company, LLC

Halyard Ortho Pack (AVID Medical) – Metal Flake Risk (2024)

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

High

FDASep 20, 2024Nationwide• AVID Medical, Inc.

Stay Informed

Fresenius Kabi Compounding, LLC Recalls

Recall Summary

Thiamine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Adult Cough Medicine (Denison) – Crystallization Issue (2024)

Kids Cough Medicine (Denison) – Crystallization Issue (2024)

Aston Martin DBX707 (Aston Martin) – Oil Cooler Hose (2024)

Quest Spectrum 3 System (Olympus) – EMC Compliance (2024)

Vial2Bag Advanced (West Pharmaceutical) – Packaging Damage (2024)

Grabeez Big Cheese Snack Mix (Tropical Nut) – Undeclared Nuts (2024)

Dapsone Gel (Viona) – Crystallization Problem (2024)

Atorvastatin Tablets (Nivagen) – Foreign Tablet Contamination (2024)

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Sour Charlie Bread (Salt City Baking) – Undeclared Wheat (2024)

Halyard Ortho Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Pacemaker Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Endovascular Kit (AVID Medical) – Metal Flake Risk (2024)

Halyard Total Knee Kit (AVID Medical) – Metal Flake Risk (2024)

Halyard Manifold Cath Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Post Partum Tubal Ligation Kit (AVID Medical) – Metal Flake Risk (2024)

Halyard EP Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Interventional Tray (AVID Medical) – Metal Flake Risk (2024)

Halyard C Section Pack (AVID Medical) – Metal Flake Risk (2024)