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Showing 1–20 of 479 results

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Heimishe Matjes Herring (Kosher First) – undeclared color (2025)

Undeclared Allergen

Undeclared FD&C Red #40

Class IIILow

FDANov 10, 2025NY• Kosher First LLC

FentaNYL Citrate PF Injection (STAQ Pharma) – Labeling Error (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIIModerate

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

Ketamine HCl Injection (STAQ Pharma) – Labeling Issue (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIIHigh

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

Hydromorphone HCL PF Injection (STAQ Pharma) – Labeling Error (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIILow

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

Espumil Foam Base (Letco Medical) – Labeling Problem (2025)

Labeling: Not Elsewhere Classified

Class IIIModerate

FDASep 12, 2025AL• Letco Medical LLC

Toasted Cherry Biscotti (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Contains undeclared Red 40

Class IIIHigh

FDASep 10, 2025CT• Gina Marie Bakery LLC

TopCare Health Isopropyl Alcohol (Consumer Product Partners) - Contamination (2025)

Cross Contamination with Other Products.

Class IIIModerate

FDAAug 25, 2025Nationwide• Consumer Product Partners, LLC

Kroger Isopropyl Alcohol (Consumer Product Partners) - Contamination (2025)

Cross Contamination with Other Products.

Class IIIModerate

FDAAug 25, 2025Nationwide• Consumer Product Partners, LLC

UDK Half Plum (Sungal) – Cyclamate adulteration (2025)

Cyclamate adulteration

Class IIIHigh

FDAAug 8, 2025CA, MD, NY +1 more• SUNGAL INC

Sensodyne PRONAMEL (Haleon) - Labeling Mix-up (2025)

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

Class IIILow

FDAAug 5, 2025Nationwide• Haleon US Holdings LLC

Albuterol Sulfate Inhaler (Cipla) – Particle Size Failure (2025)

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

Class III

FDAJul 24, 2025Nationwide• Cipla USA, Inc.