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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

All product recalls associated with The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories.

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Recall Summary

Total Recalls

1000

Past Year

100

Class I (Serious)

Most Recent

Dec 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 21–40 of 2670 recalls

ChlorproMAZINE Hydrochloride Tablets (Major Pharmaceuticals) – N-Nitroso impurity (2025)

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Class IIModerate

FDASep 12, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Storyteller Overland GXV Hilt (Storyteller) – Wiring Issue (2026)

Fire/Burn Risk

Storyteller Overland, LLC (Storyteller) is recalling certain 2024-2026 GXV Hilt recreational vehicles. The auxiliary power system wires may have been improperly. The wires may be damaged by contact with the intake manifold.

High

NHTSASep 9, 2025Nationwide• STORYTELLER OVERLAND

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

123 4...134

Page 2 of 134Next

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

FDASep 2, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Vanilla G. Nutt Ice Cream (I C F Factory) – Undeclared Almond (2025)

Undeclared Allergen

May contained undeclared almond

Class IIModerate

FDAAug 29, 2025NY• I C F Factory Inc

Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Superpotent drug

Class IIModerate

FDAAug 28, 2025Nationwide• Ascend Laboratories, LLC

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (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 20, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

RayStation Software (RaySearch) – UID uniqueness (2025)

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Low

FDAAug 8, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

FloPatch FP120 (Flosonics) – expiry date error (2025)

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Low

FDAAug 7, 2025Nationwide• Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada

2023 Storyteller Overland Mode LT (Storyteller) – shore power inlet (2025)

Fire/Burn Risk

Storyteller Overland, LLC (Storyteller) is recalling certain 2023 Mode LT recreational vehicles. The exterior shore power inlet may have been improperly tightened.

High

NHTSAJul 31, 2025Nationwide• STORYTELLER OVERLAND

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications: low dissolution results

Class IIModerate

FDAJul 21, 2025Nationwide• Ascend Laboratories, LLC

Sucralfate Tablets (Nostrum Laboratories) – Quality Program Disruption (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 11, 2025Nationwide• Nostrum Laboratories, Inc.

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class IIModerate

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Downstream recall of a dietary supplement ingredient that was manufactured out of specification.

Class IIILow

FDAJun 24, 2025CA, IN, OK• GMP Laboratories of America Inc

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

Class IIILow

FDAJun 24, 2025CA, IN, OK• GMP Laboratories of America Inc

Golf Car Vehicles (Yamaha) – Crash Hazard (2025)

Yamaha is expanding the following recalls to include more units and a more comprehensive repair: · Yamaha Golf Car Vehicles About 352,000 (Yamaha previously recalled 11,000 golf cars on July 6, 2023; 5,000 on February 17, 2022; 145,000 on October 3, 2018 and 161,000 on February 22, 2018.) · Yamaha Golf Car Company Recalls Model Year 2023 Golf Cars, Personal Transportation Vehicles and Umax Due to Crash and Injury Hazards and Risk of Death (Recall Alert) | CPSC.gov · Yamaha Recalls Golf Cars and Personal Transportation Vehicles Due to Risk of Injury or Death (Recall Alert) | CPSC.gov · Yamaha Recalls Golf Cars, Personal Transportation and Specialty Vehicles Due to Crash Hazard (Recall Alert) | CPSC.gov · Yamaha Recalls Golf Cars and Personal Transportation Vehicles Due to Crash Hazard (Recall Alert) | CPSC.gov. This recall expansion now includes model year 2016 Yamaha Drive Gas/Electric, model years 2017-2024 Drive 2 Gas/Electric, model years 2016-2018 Adventurer, and model years 2019-2024 UMAX golf car vehicles. The recalled golf cars were sold in a variety of colors. The following models and serial number ranges are included in this recall expansion. The model name is located on the left and right side of the vehicle. Serial numbers are located in various locations depending on the vehicle model. If you are unable to locate your serial number, contact Yamaha for assistance. Model Year Model Name Serial Number Prefix From To 2016 DRIVE PTV (EFI) JC0 0700101 0706598 DRIVE PTV (48V - DC MOTOR) JC1 0700107 0703500 DRIVE FLEET (EFI) JC2 0300101 0312000 DRIVE FLEET (48V - AC MOTOR) JC3 000101 004700 ADVENTURER TWO (48V - AC MOTOR) JW3 0100129 0200105 ADVENTURER ONE (EFI) JW6 0800101 0900149 ADVENTURER TWO (EFI) JW7 0700101 0800199 DRIVE FLEET (CARB) JW8 0600101 0614300 DRIVE FLEET (48V - DC MOTOR) JW9 0600101 0618100 2017 Drive2 Fleet (Carb) J0A 000101 010100 Drive2 QuieTech J0B 000101 016900 DRIVE² FLEET (48V - DC MOTOR) J0C 000101 011400 Drive2 QuieTech PTV J0D 000101 101480 Drive2 Powertech AC PTV J0E 000101 002900 Drive2 AC J0J 000101 001999 ADVENTURER TWO (48V - AC MOTOR) JW3 0200102 0200222 ADVENTURER ONE (EFI) JW6 0900103 0900400 ADVENTURER TWO (EFI) JW7 0800101 0800750 2018 Drive2 Fleet (Carb) J0A 0100101 0110400 Drive2 QuieTech J0B 0100101 0119200 DRIVE² FLEET (48V - DC MOTOR) J0C 0100101 0111700 Drive2 QuieTech PTV J0D 0100113 0110600 Drive2 Powertech AC PTV J0E 0020300102600 Drive2 AC J0J 0100101 0102700 ADVENTURER TWO (48V - AC MOTOR) JW3 0300101 0300225 ADVENTURER ONE (EFI) JW6 0910101 0910500 ADVENTURER TWO (EFI) JW7 0900101 0900773 2019 Drive2 Fleet (Carb) J0A 0200101 0203195 Drive2 QuieTech J0B 0200101 0219500 DRIVE² FLEET (48V - DC MOTOR) J0C 0200101 0210208 Drive2 QuieTech PTV J0D 0200101 0209500 Drive2 Powertech AC PTV J0E 0200134 0202300 UMAX One EFI J0F 000101 001110 UMAX Two EFI J0G 000101 001610 UMAX TWO AC J0H 000101 000550 Drive2 AC J0J 0200101 0202569 Drive2 EFI J0K 000101 211640 UMAX One Rally EFI J0L 000101 000350 UMAX Two Rally EFI J0M 000101 000350 UMAX Two Rally AC J0N 000101 000150 UMAX Rally 2+2 AC J0P 000101 000350 UMAX Two Rally 2+2 AC J0R 000101 000180 2020 Drive2 QuieTech J0B 0300101 0401812 DRIVE² FLEET (48V - DC MOTOR) J0C 0300101 0305750 Drive2 QuieTech PTV J0D 0300104 0307300 Drive2 Powertech AC PTV J0E 0300101 0302800 UMAX One EFI J0F 0100101 0100570 UMAX Two EFI J0G 0100101 0101100 UMAX TWO AC J0H 0100101 0100540 Drive2 AC J0J 0300101 0301048 Drive2 EFI J0K 0100101 0108500 UMAX One Rally EFI J0L 0100101 0100110 UMAX Two Rally EFI J0M 0100101 0100130 UMAX Two Rally AC J0N 0100101 0100170 UMAX Rally 2+2 AC J0P 0100101 0100610 UMAX Two Rally 2+2 AC J0R 0100101 0100160 2021 Drive2 QuieTech J0B 0400101 0419500 Drive2 QuieTech PTV J0D 0302688 0411600 Drive2 Powertech AC PTV J0E 0400101 0402800 UMAX One EFI J0F 0200101 0200460 UMAX Two EFI J0G 0200141 0200750 UMAX TWO AC J0H 0200147 0200420 Drive2 AC J0J 0400101 0414900 Drive2 EFI J0K 0200101 0214100 UMAX One Rally EFI J0L 0200102 0200141 UMAX Two Rally EFI J0M 0200102 0200161 UMAX Two Rally AC J0N 0200102 0200131 UMAX Rally 2+2 AC J0P 0200102 0200481 UMAX Two Rally 2+2 AC J0R 0200102 0200121 Drive2 Powertech AC J0S 0000101 0002200 Concierge 4 J2D 0000101 0000898 2022 Drive2 QuieTech J0B 0500101 0522400 Drive2 QuieTech PTV J0D 0500108 0514500 Drive2 Powertech AC PTV J0E 0500101 0502134 UMAX One EFI J0F 0300101 0300640 UMAX Two EFI J0G 0300101 0301100 UMAX TWO AC J0H 0300101 0300630 Drive2 AC J0J 0500101 0508700 Drive2 EFI J0K 0300101 0313300 UMAX One Rally EFI J0L 0300101 0300210 UMAX Two Rally EFI J0M 0300101 0300280 UMAX Two Rally AC J0N 0300101 0300110 UMAX Rally 2+2 AC J0P 0300101 0300580 UMAX Two Rally 2+2 AC J0R 0300101 0300170 Drive2 Powertech AC J0S 0100101 0101100 Concierge 4 J2D 0000141 0000877 Drive2 Powertech AC Li J5A 0000101 00001800 Drive2 AC Li J5B 0000101 0000600 Drive2 Powertech AC Li PTV J5C 0000101 00001400 Drive 2 QuieTech J0B 0600108 0610794 Drive 2 QuieTech PTV J0D 0600129 0607464 Drive 2 Powertech AC PTV J0E 0600426 0600987 UMAX One EFI J0F 0600426 0600987 UMAX Two EFI J0G 0400118 0400641 UMAX TWO AC J0H 0400102 0400398 Drive 2 AC J0J 0600434 0607512 Drive 2 EFI J0K 0307486 0406528 UMAX One Rally EFI J0L 0400110 0400127 UMAX Two Rally EFI J0M 0400251 0400251 UMAX Rally 2+2 AC J0P 0400193 0400400 Drive 2 Powertech AC J0S 0200189 0200189 Concierge 4 J2D 0000162 0000900 GATOR GS GAS J3G 0000114 0000250 GATOR GS ELECTRIC J3H 0000126 0000225 Drive 2 Powertech AC Li J5A 0100412 0102015 Drive 2 AC Li J5B 0100398 0102396 Drive 2 Powertech AC Li PTV J5C 0100118 0101671 2024 Drive 2 Powertech AC Li PTV J0B 0700204 0711501 Drive 2 QuieTech J0D 0700102 0700898 Drive 2 QuieTech PTV J0E 0700158 0700158 Drive 2 Powertech AC PTV J0G 0500136 0500136 UMAX Two EFI J0J 0701462 0705438 Drive 2 AC J0K 0500439 0510891 Drive 2 EFI J0P 0500129 0500129 UMAX Rally 2+2 AC J3G 0100278 0100278 GATOR GS GAS J3H 0100103 0100103 GATOR GS ELECTRIC J5B 0200398 0202095 Drive 2 AC Li J0B 0700204 0711501

High

CPSCJun 5, 2025Nationwide• Yamaha Motor Corporation U.S.A., of Cypress, California

Battle Motors LET2 (Battle Motors) – Steering Nut Problem (2025)

Battle Motors, Inc. (Battle Motors) is recalling certain 2024-2025 Let2 trucks. The steering wheel retaining nut may have been improperly tightened, allowing the steering wheel to loosen and detach from the steering shaft.

Very High

NHTSAJun 2, 2025Nationwide• BATTLE MOTORS

Lidocaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride 50mg Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC