Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported September 8, 2021
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, I
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
China Gel Inc recalled CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2… - a moderate-severity action.
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2… was recalled by China Gel Inc in September 8, 2021. Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepac…. Check the official notice for the remedy. Verify recall #D-0789-2021 with the FDA Drug before acting.
The recall
China Gel Inc issued this moderate-severity FDA Drug recall-CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepac….
- Moderate
- severity level
- 40K units
- affected scope
- Class II
- classification
- September 8, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0789-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0789-2021) 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 list the affected scope as 40,289 each.
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.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
40,289 each
Related Recalls
6
0 from same agency
Product description
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,
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0789-2021 |
| Date reported | September 8, 2021 |
| Date initiated | March 10, 2021 |
| Recalling firm | China Gel Inc |
| Firm location | Arlington Heights, IL |
| Affected scope | 40,289 each |
| 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0789-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by China Gel Inc. Units affected: 40,289 each.
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-0789-2021.
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-0789-2021) 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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 8, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.