The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls

18 recalls on record · latest: September 12, 2025

Official U.S. recall history for The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, compiled from official government records.

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Major ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

September 12, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Major ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

September 12, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Major ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

September 12, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Major ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

September 12, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Major ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

September 12, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per…

September 2, 2025 · Drug & medication recalls Moderate risk Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, us…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per ba…

September 2, 2025 · Drug & medication recalls Moderate risk Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, us…

Carvedilol Tablets USP recalled over manufacturing violations

August 20, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ob…

ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

April 14, 2025 · Drug & medication recalls Moderate risk CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Dist…

March 4, 2025 · Drug & medication recalls Failed Dissolution Specifications: Out of specification results obtained during…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),…

January 30, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product conta…

January 21, 2025 · Drug & medication recalls Moderate risk Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specif…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product conta…

January 21, 2025 · Drug & medication recalls Moderate risk Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specif…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product con…

January 21, 2025 · Drug & medication recalls Moderate risk Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specif…

Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations

January 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSR…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indiana…

November 7, 2024 · Drug & medication recalls Moderate risk Failed Impurity/Degradation Specifications

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianap…

November 7, 2024 · Drug & medication recalls Moderate risk Failed Impurity/Degradation Specifications

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Br…

November 5, 2024 · Drug & medication recalls Failed Impurities/Degradation Specifications; during routine stability testing…