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Abbott Molecular, Inc.

Abbott Molecular, Inc. Recalls

All product recalls associated with Abbott Molecular, Inc..

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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 2881–2900 of 25002 recalls

Vysis MDM2 FISH Probe Kit (Abbott) – Export Specification Mismatch (2024)

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

Low

FDAFeb 1, 2024Nationwide• Abbott Molecular, Inc.

Spinach & Feta Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Class III

1...143 144145146 147...1251

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Low

FDAFeb 1, 2024Nationwide• Amerisource Health Services LLC

TING Tolnaftate Spray (Insight) – Benzene Contamination (2024)

Chemical Contamination; presence of benzene.

Class IHigh

FDAFeb 1, 2024Nationwide• Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Lansoprazole Capsules (NATCO Pharma) – Inadequate Sealing (2024)

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Class IIModerate

FDAFeb 1, 2024Nationwide• NATCO Pharma Limited

Plain Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Meta Psyllium Fiber Capsules (Procter & Gamble) – Illegible Label (2024)

Illegible Label

Class IIModerate

FDAFeb 1, 2024AL, AZ, AR +38 more• The Procter & Gamble Company

Chocolate Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Ham & Cheese Croissant (Frothy Monkey) – Metal Fragments (2024)

Potential Foreign Material - Metal Fragments

Class IIModerate

FDAFeb 1, 2024AL, TN• Bakery by Frothy Monkey

Microalbumin Calibrator (Randox) – Result Misclassification (2024)

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

Moderate

FDAJan 31, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Mini Stick Max 5F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

Moderate

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.