Hand Sanitizer Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling 50,000 units of hand sanitizer because stability testing was not conducted.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a documentation and testing deviation rather than a direct safety hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 50,000 units of Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC. The product was manufactured in China and distributed to seven consignees located in China.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured hand sanitizer products. The affected lots are 20180410, 20180411, 20180830, and 20180831.
The U.S. Food and Drug Administration has classified this as a Class III recall. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
- Manufacturer
- NingBo Huize Commodity Co.,Ltd.
- Category
- Drug — OTC Hand Sanitizer
- Affected units
- 50,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 20180410
- Exp 4/9/2020
- 20180411
- Exp 4/10/2020
- 20180830
- Exp 8/29/2020
- 20180831
- Exp 8/30/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 36 recalled by NingBo Huize Commodity Co.,Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 36 products in this recall →Related recalls
Same manufacturer · NingBo Huize Commodity Co.,Ltd.
See all →- LowNingBo Huize Recalls Dippin' Dots Hand Gel Due to Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowNingBo Huize Recalls Air Heads Hand Gel for Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowHand Gel Recalled for Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowNingBo Huize Recalls Strawberry Scented Antibacterial Hand Gel for CGMP Deviations
FDA (Drugs) · 2019-08-07
- LowFestpak Sunscreen Recalled for Missing Stability Testing
FDA (Drugs) · 2019-08-07
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateHand Sanitizer Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-01-25
- ModerateHand Sanitizer Recalled for Manufacturing Practice Deviations
FDA (Drugs) · 2023-01-25
- SevereFDA Recalls Protz Antibacterial Hand Sanitizer for CGMP Violations
FDA (Drugs) · 2020-12-16
- SevereHand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination
FDA (Drugs) · 2022-03-30
- SevereHand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content
FDA (Drugs) · 2020-11-25
- ModerateQiYu Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content
FDA (Drugs) · 2021-07-07