RecallRadar

FDA Drug recall D-1548-2019

TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises…

On 2019-08-07 the FDA classified a Class III recall of TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises… by Ningbo Huize Commodity, citing CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1548-2019
ClassificationClass III
Statusterminated
Initiated2019-04-01
Published2019-08-07
Last updated2026-09-13 11:52 UTC
CompanyNingbo Huize Commodity
Distributionn/a

Product

TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

Reason

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Identifiers

code_infoLot #: 20181112, Exp 11/11/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1548-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.