CLASS III Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report
Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand recalled
NingBo Huize Commodity Co is recalling Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand Gel (Ethyl Alcohol 62%). The recall was initiated on 1 Apr 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1548-2019
- FDA event ID
- 83018
- Recalling firm
- NingBo Huize Commodity Co, Yuyao, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Apr 2019
- FDA classified
- 27 Jul 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 1 Apr 2019 | Recall initiated by company | |
| 27 Jul 2019 | Classified by FDA | +117 days |
| 7 Aug 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Foreign manufacturer located in China and distributed to seven consignees located in China.
Questions about this recall
Is Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand Gel (Ethyl Alcohol 62%) recalled?
Yes. NingBo Huize Commodity Co recalled Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand Gel (Ethyl Alcohol 62%) on 1 Apr 2019. The recall is Class III and its status is Terminated. Recall number D-1548-2019.
Why was it recalled?
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Which lots are affected?
Lot #: 20181112, Exp 11/11/2020
Where was it sold?
Foreign manufacturer located in China and distributed to seven consignees located in China.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.