Severity
Moderate
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,
Reported: September 8, 2021 Initiated: March 10, 2021 #D-0790-2021 3458 tubes units
China Gel Inc issued this FDA Drug recall on September 8, 2021. Classified as Moderate severity (Class II). Approximately 3458 tubes units are affected. The recall was issued because: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was fou…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Drug action (record #D-0790-2021) was formally reported on September 8, 2021, with the manufacturer initiating the action on March 10, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. China Gel Inc is listed as the recalling firm, operating out of Arlington Heights, IL. Federal records indicate 3458 tubes units are affected.
The documented reason for this recall is: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
3458 tubes
Related Recalls
6
0 from same agency
Product Description
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,
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.
Details
- Recalling Firm
- China Gel Inc
- Units Affected
- 3458 tubes
- Distribution
- Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
- Location
- Arlington Heights, IL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0790-2021 |
| Date reported | September 8, 2021 |
| Date initiated | March 10, 2021 |
| Recalling firm | China Gel Inc |
| Units affected | 3458 tubes |
| Distribution | Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by China Gel Inc. Units affected: 3458 tubes.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on September 8, 2021. Severity: Moderate. Recall number: D-0790-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0790-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Recall Guides
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).