QiYu Hand Sanitizer Gel recalled for subpotency
World Source LLC is recalling QiYu Hand Sanitizer Gel (500 mL bottles) distributed to two hospitals in New York because the product is subpotent—meaning it contains less active ingredient than specified.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary recall involving subpotency (reduced active ingredient) with no reported illnesses or injuries. While subpotent hand sanitizer poses a theoretical safety risk by not meeting efficacy standards, the source text contains no reports of actual harm, placing this in the Moderate category per the rubric.
Plain-English summary
World Source LLC is recalling QiYu Hand Sanitizer Gel, an ethanol-based hand sanitizer sold in 500 mL pump bottles. The product was manufactured by Guangzhou Minghui Cosmetics Co., Ltd. Approximately 6,300 bottles were affected, with manufacturer lot number 20200320 and an expiration date of March 2022.
The recall was initiated because the product is subpotent—it does not contain the required concentration of active sanitizing ingredient. This means the product may not provide the intended level of antimicrobial protection.
The product was distributed to two hospitals in New York. This is a voluntary recall initiated by the firm on June 9, 2021, and was classified as FDA Class II. The recall was terminated on June 9, 2022.
The recalled product
- Product
- QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
- Manufacturer
- World Source Llc
- Category
- Drug — Hand Sanitizer
- Affected units
- 6,300
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 (3)
- Manufacturer's lot # 20200320
- exp. date March 2022 WorldSource LLC
- Item # TCM004
Distribution
Distributed in 1 state:
Related recalls
Same hazard · subpotency
See all →- SeverePfizer Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-10-28
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
Similar recalls
- ModerateQiYu Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content
FDA (Drugs) · 2021-07-07
- ModerateQiYu Hand Sanitizer 75% Ethyl Alcohol Recalled for Subpotency
FDA (Drugs) · 2021-09-15
- ModerateHand Sanitizer Recalled for Subpotent Ethyl Alcohol Content
FDA (Drugs) · 2025-06-11
- ModerateHand Sanitizer Recalled for Subpotent Alcohol and High pH Levels
FDA (Drugs) · 2020-08-05
- ModeratePremium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol Content
FDA (Drugs) · 2022-03-02
- SevereSYP Health Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-12-02