CLASS II ONGOING Drug recall · Reported 8 Sep 2021 · FDA Enforcement Report
aulief (Organic Camphor 3.00% Organic Menthol 5.00%) recalled
China Gel is recalling aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a), 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-0790-2021
- FDA event ID
- 87496
- Recalling firm
- China Gel, Arlington Heights, IL
- Brand
- Aulief
- 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
aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; 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) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
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 87496This product is part of a recall event; the main page for the event is White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever recalledChina-gel | China Gel | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A Topical Pain recalledChina-gel | China Gel | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from China Gel
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A Topical Pain recalledChina-gel | China Gel | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever recalledChina-gel | China Gel | Manufacturing (CGMP) Deviations | Nationwide |
Other Menthol recalls
All 9| 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 | Wecare Calasoothe recalled by Blossom PharmaceuticalsMenthol And Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | 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 | Theracare Cold Hot Medicated Patch, Menthol 5%, 5 patches recalledThera Care Cold Hot Medicated Patch | Unexo Life Sciences Private | Manufacturing (CGMP) Deviations | Nationwide |