CLASS II ONGOING Drug recall · Reported 8 Sep 2021 · FDA Enforcement Report
White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever recalled
China Gel is recalling White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever, distributed nationwide in the US. The recall was initiated on 10 Mar 2021 and the FDA has classified it as Class II.
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-0789-2021
- FDA event ID
- 87496
- Recalling firm
- China Gel, Arlington Heights, IL
- Brand
- China-gel
- Manufacturer
- China-Gel, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Mar 2021
- FDA classified
- 2 Sep 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Mar 2021 | Recall initiated by company | |
| 2 Sep 2021 | Classified by FDA | +176 days |
| 8 Sep 2021 | Published in enforcement report | +6 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: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Product as listed by the FDA
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
Where it was distributed
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
Questions about this recall
Why was it recalled?
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Which lots are affected?
Lot #: a)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; b)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; c)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; d)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; e)B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; f)B100JS, Exp 04/2021; B183GQ, EXP 09-2021; B255KZ, EXP 09-2021; C030HS, EXP 04-2022; C100AH, EXP 06-2022; C247JF, EXP 10-2022;
Where was it sold?
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 87496| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A Topical Pain recalledChina-gel | China Gel | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | aulief (Organic Camphor 3.00% Organic Menthol 5.00%) recalledAulief | China Gel | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from China Gel
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | aulief (Organic Camphor 3.00% Organic Menthol 5.00%) recalledAulief | China Gel | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A Topical Pain recalledChina-gel | China Gel | Manufacturing (CGMP) Deviations | Nationwide |
Other Menthol recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | caring mill, Menthol Cough Suppressant Oral Anesthetic recalledCaring Mill Cough Drops Cherry | Xiamen Kang Zhongyuan Biotechnology | Processing Deviation | Nationwide |
| Drug | CLASS II | Artridon Glucosamine (menthol 2% and Methyl Salicylate recalledArtridon | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |
| Drug | CLASS II | HealthWise Period Patch Menstrual Pain Relief, Menthol recalledHealthwise Menstrual Pain Relief Patch | Unexo Life Sciences Private | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg) recalledNatural Cherry Honey Herb Throat Drops | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | aulief (Organic Camphor 3.00% Organic Menthol 5.00%) recalledAulief | China Gel | Manufacturing (CGMP) Deviations | Nationwide |