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The Harvard Drug Group LLC

The Harvard Drug Group LLC Recalls

All product recalls associated with The Harvard Drug Group LLC.

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Recall Summary

Total Recalls

1000

Past Year

631

Class I (Serious)

Most Recent

Jan 2026

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 301–320 of 10391 recalls

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

4 Liter Minifridge (AstroAI) – Fire Hazard (2025)

Fire/Burn Risk

This recall involves the AstroAI 4-Liter/6-Can minifridges. AstroAI is printed on the front of the units. The model and serial numbers are found on a label on the back of the minifridge. The model number is "LY0204A". The nine-digit serial number of the affected units starts with "S/N" and begins with the following numbers: 19, 20, 21, 2201, 2202 or 2203. The serial number is located on either the bottom or the middle-right portion of the label. The minifridges measure 9.45 inches in diameter x 6.9 inches wide x 10 inches high. The minifridges were sold in a variety of colors, including black, white, blue and pink.

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High

CPSCJun 18, 2025Nationwide• Shaoxing ShangYu North Electron Manufacture Co. Ltd., of China

Electric Blanket (MaxKare) – Burn Risk (2025)

Fire/Burn Risk

This recall involves MaxKare Electric Blankets with six heating levels and a nine-hour auto-off function. They were sold in three sizes: 62 inches by 84 inches (twin), 72 inches by 84 inches (full), and 84 inches by 90 inches (queen). The recall only includes model numbers HB18A-7284-1, HB18A-8490-2 and HB18A-6284-1. The brand name, MaxKare, and the model numbers are on the tag attached to the blanket. The blankets come in brown and gray and are machine washable.

High

CPSCJun 18, 2025Nationwide• Shenzhen Yumo Commerce and Trade Corporation, of China

12-Drawer White Dresser (YaFiti) – tip-over hazard (2025)

This recall involves YaFiti 12-Drawer White Dressers. The dressers measure about 39 inches long, 12 inches wide and 45 inches high and were sold in white. The model number HI1318_02 is printed on the outer packaging box of the product.

Very High

CPSCJun 18, 2025Nationwide• Shenzhen Leader-Union Technology Co. Ltd., of China

Acuvue Oasys Max Multifocal (Johnson & Johnson) – Lens Defect (2025)

Due to defects (bubbles/voids) identified during standard finished goods testing

Moderate

FDAJun 12, 2025Nationwide• Johnson & Johnson Vision Care, Inc.

Asprire Cristalle Mammography (Fujifilm) – Unapproved Software (2025)

Devices had an unapproved slabbing software function enabled for use.

Low

FDAJun 11, 2025Nationwide• FUJIFILM Healthcare Americas Corporation

Zicam Cold Remedy Nasal Swabs (Church & Dwight) – Fungal Contamination (2025)

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

Class IHigh

FDAJun 6, 2025Nationwide• Church & Dwight Inc

Zicam Nasal AllClear Swabs (Church & Dwight) – Fungal Contamination (2025)

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

Class IHigh

FDAJun 6, 2025Nationwide• Church & Dwight Inc

Orajel Baby Teething Swabs (Church & Dwight) – Fungal Contamination (2025)

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.

Class IHigh

FDAJun 6, 2025Nationwide• Church & Dwight Inc

Apollo Smoke and CO Detectors (Apollo America) – Alert Failure (2025)

Fire/Burn Risk

This recall involves Apollo America Combination Smoke and Carbon Monoxide Detectors with model number 51000-600. The recalled detector was sold in a white color. The front of the recalled detector has the text "Replace by" followed by a date ranging from 2034/June to 2034/October. "Apollo" and the model number 51000-600 are on the back of the detector. Note: If you choose to dispose of the detector's primary/non-rechargeable lithium battery, do not throw the battery in the trash, or in the general recycling stream (e.g., street-level or curbside recycling bins). Lithium batteries must be disposed of differently than other batteries, because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center or battery recycling boxes found at various retail and home improvement stores may accept this lithium battery for disposal. Before taking your battery to a HHW collection center, contact that office ahead of time and ask whether it accepts lithium batteries. If it does not, contact your municipality for further guidance.

Very High

CPSCJun 5, 2025Nationwide• Apollo America Inc., of Auburn Hills, Michigan

NIO-A Intraosseous Device (Waismed) – Stabilizer Deployment Problem (2025)

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

High

FDAJun 5, 2025Nationwide• Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel

NIO+ Intraosseous Device (Waismed) – Stabilizer Deployment Problem (2025)

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

High

FDAJun 5, 2025Nationwide• Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel

Hammer Ball Sets (Shantou Jinshanglu) - Choking Hazard (2025)

Choking Hazard

This recall involves Hobby Toy Hammer Ball sets with model number 711. The model number is printed on the label of the product packaging. The toy set consists of a base with buttons, a detachable door, four small detachable basins, and a standing sign with a monkey. "FOREST ROLLER BALL" is printed on the green base of the toy sets. "ROLLER BALL" is printed on the brown gate and "FISHING" is printed on the side of the hammer on these toys. The hammer ball sets measure 15 x 10.6 x 13.2 inches and come with a hammer and four small colored balls. The balls measure about 1.5 inches in diameter and were sold in yellow, light pink, dark pink and blue.

Moderate

CPSCJun 5, 2025Nationwide• Shantou Jinshanglu Toys Industry Co. Ltd., of China

ADVIA Calibrator (Siemens Healthcare) – Platelet Value Error (2025)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Moderate

FDAJun 4, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

High

FDAJun 4, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

ADVIA 3-in-1 Control (Siemens Healthcare) – Platelet Value Error (2025)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Moderate

FDAJun 4, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Zvu Anorectal Manometry Kit (Diversatek) – Expiration Date Mislabel (2025)

Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.

Moderate

FDAJun 4, 2025Nationwide• Diversatek Healthcare

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