The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Complete recall history across all FDA and CPSC categories — 24 total recalls

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (24)

FDA drug safety enforcement actions by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Date Product Reason Class
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bli... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) b... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 2, 2025 Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 T... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, ... Class II
Sep 2, 2025 Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Ta... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, ... Class II
Aug 20, 2025 Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Pack... CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ... Class II
Apr 14, 2025 ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 ... CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity abov... Class II
Mar 4, 2025 Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... Failed Dissolution Specifications: Out of specification results obtained duri... Class III
Jan 30, 2025 Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablet... Failed Dissolution Specifications. Class II
Jan 21, 2025 Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blist... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-spec... Class II
Jan 21, 2025 Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blist... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-spec... Class II
Jan 21, 2025 Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 bli... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-spec... Class II
Jan 13, 2025 Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses ... CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (ND... Class II
Nov 7, 2024 Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceutic... Failed Impurity/Degradation Specifications Class II
Nov 7, 2024 Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceutica... Failed Impurity/Degradation Specifications Class II
Nov 5, 2024 Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distribu... Failed Impurities/Degradation Specifications; during routine stability testin... Class III
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained durin... Class II
Feb 9, 2024 HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... an out of specification result obtained during routine stability testing for ... Class II
Oct 31, 2023 Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 31, 2023 Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 23, 2023 Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL uni... Failed Content Uniformity Specifications Class I
May 31, 2023 ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochlorid... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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