--- title: "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/the-harvard-drug-group-llc-dba-major-pharmaceuticals-and-rugby-laboratories/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall records **13** reported ongoing 24 records in this archive. Latest source date Sep 12, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Sep 12, 2025 FDA drug enforcement ### [Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, US...](https://isitonrecall.com/recall/fda-drug-d-0009-2026-major-chlorpromazine-hydrochloride-tablets-usp-25-mg-50-tablets-5x10-blister-package-rx-only-package/) CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II Reported ongoing Distribution: Nationwide [Official source for Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0009-2026%22) Sep 12, 2025 FDA drug enforcement ### [Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, ...](https://isitonrecall.com/recall/fda-drug-d-0010-2026-major-chlorpromazine-hydrochloride-tablets-usp-25-mg-100-tablets-10x10-blister-package-rx-only-packa/) CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II Reported ongoing Distribution: Nationwide [Official source for Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx O...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0010-2026%22) Sep 12, 2025 FDA drug enforcement ### [Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268,...](https://isitonrecall.com/recall/fda-drug-d-0011-2026-major-chlorpromazine-hydrochloride-tablets-usp-50-mg-100-tablets-10x10-blister-package-rx-only-packa/) CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II Reported ongoing Distribution: Nationwide [Official source for Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0011-2026%22) Sep 12, 2025 FDA drug enforcement ### [Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268,...](https://isitonrecall.com/recall/fda-drug-d-0012-2026-major-chlorpromazine-hydrochloride-tablets-usp-100-mg-100-tablets-10x10-blister-package-rx-only-pack/) CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II Reported ongoing Distribution: Nationwide [Official source for Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0012-2026%22) Sep 12, 2025 FDA drug enforcement ### [Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268,...](https://isitonrecall.com/recall/fda-drug-d-0013-2026-major-chlorpromazine-hydrochloride-tablets-usp-200-mg-100-tablets-10x10-blister-package-rx-only-pack/) CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II Reported ongoing Distribution: Nationwide [Official source for Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0013-2026%22) Sep 2, 2025 FDA drug enforcement ### [Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharm...](https://isitonrecall.com/recall/fda-drug-d-0624-2025-sulfamethoxazole-and-trimethoprim-usp-800-mg-160-mg-double-strength-100-tablets-unit-dose-blister-pa/) 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 II Reported ongoing Distribution: USA Nationwide. [Official source for Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose bli...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0624-2025%22) Sep 2, 2025 FDA drug enforcement ### [Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 430...](https://isitonrecall.com/recall/fda-drug-d-0625-2025-sulfamethoxazole-and-trimethoprim-usp-800-mg-160-mg-double-strength-10-tablets-unit-dose-blister-pac/) 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 II Reported ongoing Distribution: USA Nationwide. [Official source for Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blis...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0625-2025%22) Aug 20, 2025 FDA drug enforcement ### [Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61](https://isitonrecall.com/recall/fda-drug-d-0594-2025-carvedilol-tablets-usp-12-5-mg-100-tablets-10x10-cartons-rx-only-packaged-and-distributed-by-major-p/) 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 II Reported ongoing Distribution: Product was distributed nationwide within the United States. [Official source for Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0594-2025%22) Apr 14, 2025 FDA drug enforcement ### [ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268...](https://isitonrecall.com/recall/fda-drug-d-0366-2025-chlorpromazine-hydrochloride-tablets-usp-10-mg-packaged-in-cartons-of-100-tablets-10x10-rx-only-pack/) CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit Class II Reported ongoing Distribution: Nationwide USA [Official source for ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0366-2025%22) Mar 4, 2025 FDA drug enforcement ### [Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 ...](https://isitonrecall.com/recall/fda-drug-d-0304-2025-tolterodine-tartrate-extended-release-capsules-2-mg-30-capsules-3-x-10-unit-dose-carton-rx-only-pack/) Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. Class III Reported terminated Distribution: Nationwide in the USA [Official source for Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx o...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0304-2025%22) Jan 30, 2025 FDA drug enforcement ### [Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 ...](https://isitonrecall.com/recall/fda-drug-d-0221-2025-potassium-chloride-extended-release-tablets-usp-10-meq-750-mg-100-tablets-per-carton-10-x-10-unit-do/) Failed Dissolution Specifications. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0221-2025%22) Jan 21, 2025 FDA drug enforcement ### [Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pha...](https://isitonrecall.com/recall/fda-drug-d-0226-2025-lorazepam-tablets-usp-0-5mg-unit-dose-100-tablets-per-carton-10-x-10-blister-packs-rx-only-the-drug/) Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. Class II Reported ongoing Distribution: Nationwide U.S. and Puerto rico [Official source for Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0226-2025%22) Jan 21, 2025 FDA drug enforcement ### [Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharm...](https://isitonrecall.com/recall/fda-drug-d-0227-2025-lorazepam-tablets-usp-1mg-unit-dose-100-tablets-per-carton-10-x-10-blister-packs-rx-only-the-drug-pr/) Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. Class II Reported ongoing Distribution: Nationwide U.S. and Puerto rico [Official source for Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0227-2025%22) Jan 21, 2025 FDA drug enforcement ### [Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharm...](https://isitonrecall.com/recall/fda-drug-d-0228-2025-lorazepam-tablets-usp-2mg-unit-dose-100-tablets-per-carton-10-x-10-blister-packs-rx-only-the-drug-pr/) Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. Class II Reported ongoing Distribution: Nationwide U.S. and Puerto rico [Official source for Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0228-2025%22) Jan 13, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, ...](https://isitonrecall.com/recall/fda-drug-d-0212-2025-duloxetine-delayed-release-capsules-usp-20-mg-packaged-in-a-30-unit-doses-3x10-blister-packs-ndc-090/) CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit Class II Reported terminated Distribution: Nationwide within the United States [Official source for Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs)...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0212-2025%22) Nov 7, 2024 FDA drug enforcement ### [Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72](https://isitonrecall.com/recall/fda-drug-d-0049-2025-guaifenesin-dextromethorphan-syrup-200-mg-20mg-per-10-ml-major-pharmaceuticals-8401-bearing-drive-su/) Failed Impurity/Degradation Specifications Class II Reported terminated Distribution: Nationwide within the United States [Official source for Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Dri...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0049-2025%22) Nov 7, 2024 FDA drug enforcement ### [Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70](https://isitonrecall.com/recall/fda-drug-d-0050-2025-guaifenesin-dextromethorphan-syrup-100-mg-10mg-per-5-ml-major-pharmaceuticals-8401-bearing-drive-sui/) Failed Impurity/Degradation Specifications Class II Reported terminated Distribution: Nationwide within the United States [Official source for Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Driv...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0050-2025%22) Nov 5, 2024 FDA drug enforcement ### [Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, ...](https://isitonrecall.com/recall/fda-drug-d-0045-2025-hydralazine-hcl-tablets-usp-25mg-rx-only-100-tablets-per-carton-distributed-by-avet-pharmaceuticals/) Failed Impurities/Degradation Specifications; during routine stability testing for impurities. Class III Reported terminated Distribution: Nationwide in the US. [Official source for Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0045-2025%22) Jun 18, 2024 FDA drug enforcement ### [Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by:...](https://isitonrecall.com/recall/fda-drug-d-0584-2024-venlafaxine-hydrochloride-extended-release-capsules-usp-37-5mg-10-x-10-blister-card-in-one-carton-rx/) Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution. Class II Reported terminated Distribution: Nationwide. No foreign consignees. [Official source for Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one ca...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0584-2024%22) Feb 9, 2024 FDA drug enforcement ### [HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Dis...](https://isitonrecall.com/recall/fda-drug-d-0324-2024-hydralazine-hydrochloride-tablets-usp-10mg-packaged-in-100-count-10x10-blister-cards-lot-t04680-rx-o/) an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences. Class II Reported terminated Distribution: The product was distributed nationwide within the United States. [Official source for HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0324-2024%22) ## Reasons in these listed records - CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit - 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. - CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit These examples come from this result page and are not a ranking of every recall reason. ## Checking The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories ### Is there a recall on the harvard drug group llc dba major pharmaceuticals and rugby laboratories right now? This archive contains 24 records, including 13 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories](https://isitonrecall.com/check/?q=The%20Harvard%20Drug%20Group%20LLC%20dba%20Major%20Pharmaceuticals%20and%20Rugby%20Laboratories) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)