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Unichem Pharmaceuticals USA Inc.

Unichem Pharmaceuticals USA Inc. Recalls

All product recalls associated with Unichem Pharmaceuticals USA Inc..

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Recall Summary

Total Recalls

1000

Past Year

304

Class I (Serious)

34

Most Recent

Nov 2025

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 101–120 of 4747 recalls

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).

FDAAug 27, 2025Nationwide• Unichem Pharmaceuticals USA Inc.

Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 20, 2025Nationwide• Northwind Pharmaceuticals LLC

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

1...4 567 8...238

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CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 20, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Chlorpromazine Hydrochloride 50mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Sulfamethoxazole Trimethoprim (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 25mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 100mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 200mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Tavaborole Topical Solution (Viona) - Discoloration (2025)

Discoloration

Class IIModerate

FDAAug 12, 2025Nationwide• VIONA PHARMACEUTICALS INC

Atellica CH Protein Test (Siemens) – false result risk (2025)

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

FDAAug 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Class IIModerate

FDAAug 8, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Theophylline Tablets (Glenmark) - Failed Dissolution (2025)

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

Class IIModerate

FDAAug 8, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 3.125mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Taurine Performance (PrimeNutrition) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Joint-RX (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Battle Hardener Platinum (LG Sciences) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Pine Bark (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.