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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

China Gel Inc: China-Gel Topical Pain Relievers Recalled for Possible Bacterial Contamination

Agency Publication Date: September 2, 2021
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Summary

China Gel Inc. is recalling 136,219 units of various topical pain relief products, including China-Gel, China-Gel White, and Aulief, after they were manufactured in a facility where B. cepacia bacteria was found in other products. These products come in various sizes ranging from 2-ounce tubes to 128-ounce gallon containers and were distributed nationwide and internationally. This recall was initiated as a precaution because the manufacturing process did not meet safety standards, and consumers are advised to stop using these products immediately to avoid potential infection.

Risk

The products were manufactured in a facility with known contamination of Burkholderia cepacia (B. cepacia), a bacteria that can cause serious infections in people with weakened immune systems or chronic lung diseases.

What You Should Do

  1. Check your product packaging for the brand names China-Gel, China-Gel White, or Aulief in sizes ranging from 2 oz tubes to 128 oz gallon containers.
  2. Verify the NDC, UPC, and Lot numbers on your package. Affected lot numbers include a wide range of codes such as B122DY, B183GN, B262BF, C002KF, C030HT, C094LT, C275CW, C338CH, B122DX, B183GP, B262BE, C330BG, C156FF, C247JB, B100JS, B183GQ, B255KZ, C030HS, C100AH, C247JF, and B136HN with expiration dates between April 2021 and December 2022.
  3. Immediately stop using the recalled topical gel if you identify your product as part of the affected batches.
  4. Contact your healthcare provider or pharmacist for guidance if you have used this product and have concerns about your health.
  5. Return any unused product to the pharmacy or place of purchase for a refund.
  6. Contact China Gel Inc. at 1-847-255-0033 or through their website for further instructions regarding the return process.
  7. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: CHINA_GEL Topical Pain Reliever (2 oz tube)
Model:
NDC 76305-300-13
Lot Numbers:
B122DY (exp 2021-05)
B183GN (exp 2021-07)
B262BF (exp 2021-09)
C002KF (exp 2022-01)
C030HT (exp 2022-02)
C094LT (exp 2022-04)
C275CW (exp 2022-10)
C338CH (exp 2022-12)
Date Ranges: May 2021 - December 2022
Product: CHINA_GEL Topical Pain Reliever (4 oz jar)
Model:
NDC 76305-300-02
UPC Codes:
687806100042
Lot Numbers:
B122DX (exp 2021-05)
B183GP (exp 2021-07)
B262BE (exp 2021-09)
C002KF (exp 2022-01)
C030HT (exp 2022-02)
C094LT (exp 2022-04)
C275CW (exp 2022-10)
C330BG (exp 2022-12)
Date Ranges: May 2021 - December 2022
Product: CHINA_GEL Topical Pain Reliever (6 oz tube)
Model:
NDC 76305-300-03
UPC Codes:
687806100062
Lot Numbers:
B122DY (exp 2021-05)
B183GN (exp 2021-07)
B262BF (exp 2021-09)
C002KF (exp 2022-01)
C030HT (exp 2022-02)
C094LT (exp 2022-04)
C156FF (exp 2022-06)
C247JB (exp 2022-09)
C338CH (exp 2022-12)
Date Ranges: May 2021 - December 2022
Product: CHINA_GEL Topical Pain Reliever (8 oz jar)
Model:
NDC 76305-300-04
UPC Codes:
687806100082
Lot Numbers:
B122DX (Exp 05/2021)
B122DY (EXP 05-2021)
B183GP (EXP 07-2021)
B262BE (EXP 09-2021)
B262BF (EXP 09-2021)
C002KF (EXP 01-2022)
C030HT (EXP 02-2022)
C094LT (EXP 04-2022)
C156FF (EXP 06-2022)
C247JB (EXP 09-2022)
C275CW (EXP 10-2022)
C330BG (EXP 12-2022)
Date Ranges: May 2021 - December 2022
Product: CHINA_GEL Topical Pain Reliever (16 oz Bottle w/ Pump)
Model:
NDC 76305-300-03
UPC Codes:
687806100167
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 07-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 02-2022)
C100AH (EXP 04-2022)
C247JF (EXP 09-2022)
Date Ranges: April 2021 - September 2022
Product: CHINA_GEL Topical Pain Reliever (128 oz Gallon)
Model:
NDC 76305-300-06
UPC Codes:
687806101287
Lot Numbers:
B122DY (EXP 05-2021)
B183GN (EXP 07-2021)
B183GP (EXP 07-2021)
B262BF (EXP 01-2022)
C002KF (EXP 02-2022)
C030HT (EXP 02-2022)
C094LT (EXP 04-2022)
C156FF (EXP 09-2022)
C275CW (EXP 12-2022)
C338CH (EXP 05-2022)
Date Ranges: May 2021 - December 2022
Product: CHINA-GEL WHITE Topical Pain Reliever (2 oz Tube)
Model:
76305-301-13
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 07-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 02-2022)
C100AH (EXP 04-2022)
C247JF (EXP 09-2022)
Date Ranges: April 2021 - September 2022
Product: CHINA-GEL WHITE Topical Pain Reliever (4 oz jar)
Model:
NDC 76305-301-02
UPC Codes:
687806200041
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 07-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 02-2022)
C100AH (EXP 04-2022)
C247JF (EXP 09-2022)
Date Ranges: April 2021 - September 2022
Product: CHINA-GEL WHITE Topical Pain Reliever (6 oz tube)
Model:
NDC 76305-301-03
UPC Codes:
687806200065
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 07-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 02-2022)
C100AH (EXP 04-2022)
C247JF (EXP 09-2022)
Date Ranges: April 2021 - September 2022
Product: CHINA-GEL WHITE Topical Pain Reliever (8 oz Jar)
Model:
NDC 76305-301-04
UPC Codes:
687806200089
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 07-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 02-2022)
C100AH (EXP 04-2022)
C247JF (EXP 09-2022)
Date Ranges: April 2021 - September 2022
Product: CHINA-GEL WHITE Topical Pain Reliever (16 oz Bottle w/ Pump)
Model:
NDC 76305-301-05
UPC Codes:
687806200164
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 07-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 02-2022)
C100AH (EXP 04-2022)
C247JF (EXP 09-2022)
Date Ranges: April 2021 - September 2022
Product: CHINA-GEL WHITE Topical Pain Reliever (120 oz Gallon)
Model:
NDC 76305-301-06
UPC Codes:
687806201284
Lot Numbers:
B100JS (Exp 04/2021)
B183GQ (EXP 09-2021)
B255KZ (EXP 09-2021)
C030HS (EXP 04-2022)
C100AH (EXP 06-2022)
C247JF (EXP 10-2022)
Date Ranges: April 2021 - October 2022
Product: aulief Topical Pain Relief (3.2 oz tube)
Model:
NDC 76305-302-01
UPC Codes:
687806300031
Lot Numbers:
B136HN (Exp 05/2021)
Date Ranges: May 2021
Product: aulief Topical Pain Relief (7.0 oz tube)
Model:
NDC 76305-302-02
UPC Codes:
687806300079
Lot Numbers:
B136HN (Exp 05/2021)
Date Ranges: May 2021
Product: aulief Topical Pain Relief (16 oz Bottle w/ Pump)
Model:
NDC 76305-302-03
UPC Codes:
687806300161
Lot Numbers:
B136HN (Exp 05/2021)
Date Ranges: May 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87496
Status: Active
Manufacturer: China Gel Inc
Manufactured In: United States
Units Affected: 3 products (92,472 each; 40,289 each; 3458 tubes)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.