CLASS II ONGOING Drug recall · Reported 8 Sep 2021 · FDA Enforcement Report

CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A Topical Pain recalled

China Gel is recalling CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A Topical Pain Reliever, packaged as a) tube, 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

Lot, batch or date codesLot #: a)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; b) 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 c) 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. d)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; 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) 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;

NDC76305-300

UPC0687806100167, 687806100082, 687806100167, 687806101287

Quantity recalled92,472 each

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-0788-2021
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 (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; 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

Nationwide

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)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; b) 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 c) 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. d)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; 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) 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;

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

This 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
8 Sep 2021	CLASS II	White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever recalledChina-gel	China Gel	Manufacturing (CGMP) Deviations	Nationwide
8 Sep 2021	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
8 Sep 2021Drug	CLASS II	aulief (Organic Camphor 3.00% Organic Menthol 5.00%) recalledAulief	China Gel	Manufacturing (CGMP) Deviations	Nationwide
8 Sep 2021Drug	CLASS II	White (Camphor 3.00%, Menthol 5.00%), A Topical Pain Reliever recalledChina-gel	China Gel	Manufacturing (CGMP) Deviations	Nationwide

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