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Showing 601–620 of 806 results

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niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

Timolol Maleate Eye Solution (FDC Limited) - Defective Container (2025)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAApr 18, 2025Nationwide• FDC Limited

Beijing Soybean Paste (May Flower) – Undeclared Wheat (2025)

Undeclared Gluten

Product contains undeclared wheat.

Class IIModerate

FDAApr 17, 2025AZ, CA, ID +9 more• May Flower International Inc

Peeled Mango Pickle (Advance Food) – elevated lead levels (2025)

Product contains elevated levels of lead (0.0649 mg/kg)

Class IIModerate

FDAApr 16, 2025CT, MD, MA +3 more• Advance Food International Inc.

FentaNYL and Ropivacaine (Apollo Care) – Sterility Issue (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAApr 15, 2025MO• Apollo Care, LLC

Dexonto Dexamethasone (Nubratori) – Incorrect Labeling (2025)

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.

Class IIModerate

FDAApr 15, 2025CA, PA• Nubratori, Inc

Cilantro Salsa (MegaMex Foods) – foreign wood pieces (2025)

Firm's salsa product was potentially manufactured with a recalled ingredient (Fresh Cilantro containing foreign objects "wood pieces")

Class IIModerate

FDAApr 14, 2025CA, IN, MI +3 more• MegaMex Foods LLC

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 14, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

Testosterone Cypionate Injection (Eugia US LLC) – Crystal Dissolution Issue (2025)

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Class IIModerate

FDAApr 10, 2025Nationwide• Eugia US LLC

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 88mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 50mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Hemopropin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

Kapsin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

Wegovy (Cardinal Health) – Temperature Storage Abuse (2025)

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

Class IIModerate

FDAApr 9, 2025NC, SC, VA• Cardinal Health Inc.

Texas Olive Pepperoncini (All American Trading) – contamination risk (2025)

The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.

Class IIModerate

FDAApr 4, 2025MS, TX• All American Trading Of Houston, Inc.

Texas Olive Capers (All American Trading) – contamination risk (2025)

The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.

Class IIModerate

FDAApr 4, 2025MS, TX• All American Trading Of Houston, Inc.

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