Tootsie Roll Grape Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape Scented Antibacterial Hand Gel 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation/process issue (missing stability testing) with no reported illnesses.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape Scented Antibacterial Hand Gel (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL. The product is an over-the-counter (OTC) item distributed by JFL Enterprises, Inc. in Cleveland, Ohio, and manufactured in China.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured sunscreen and hand sanitizer OTC products. The source text does not report any illnesses or injuries associated with this recall.
The recall involves 5,112 units with Lot # 20181018 and an expiration date of 10/17/2020. The distribution pattern indicates the foreign manufacturer is located in China and the product was distributed to seven consignees located in China. Consumers should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- Product
- Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
- Manufacturer
- NingBo Huize Commodity Co.,Ltd.
- Category
- Drug — OTC Hand Sanitizer
- Affected units
- 5,112
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 (2)
- Lot #: 20181018
- Exp 10/17/2020
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 SPF 30 Sunscreen Lotion Due to Missing Stability Testing
FDA (Drugs) · 2019-08-07
- 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
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
- ModerateQiYu Hand Sanitizer 75% Ethyl Alcohol Recalled for Subpotency
FDA (Drugs) · 2021-09-15
- LowTween Brands Recalls Grape Anti-Bac Hand Sanitizer Due to Label Error
FDA (Drugs) · 2013-12-25
- SevereCVS Health Lubricating Gel Drops Recalled Due to Non-Sterility
FDA (Drugs) · 2024-02-14
- ModerateQiYu Hand Sanitizer Gel recalled for subpotency
FDA (Drugs) · 2021-06-23
- SevereLUX EOI Hand Sanitizing Gel Recalled for Methanol Contamination
FDA (Drugs) · 2020-09-23
- SevereCVS Health Lubricating Gel Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27