Topical Pain Relief AULIEF Recalled for Facility Contamination Risk
China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a pathogenic contamination risk (Burkholderia cepacia) at the manufacturing facility. Although no illnesses have been reported and the hazard is facility-based rather than confirmed in the product itself, B. cepacia is an opportunistic pathogen that can cause serious respiratory infections in immunocompromised individuals, warranting a High severity rating.
Plain-English summary
China Gel Inc is recalling AULIEF (Menthol and Camphor) topical pain relief in three package sizes: 3.2 oz tubes, 7.0 oz tubes, and 16 oz bottles with pump. All affected units are from Lot B136HN with expiration 05/2021.
The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. Specifically, the product was manufactured in the same facility where Burkholderia cepacia contamination was detected in other products.
Approximately 3,458 units were distributed nationwide in the USA as well as internationally to Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, and the United Kingdom.
Consumers who have purchased AULIEF should discontinue use and contact China Gel Inc or their healthcare provider for further guidance.
The recalled product
- Product
- AULIEF (MENTHOL AND CAMOHOR)
- Brand
- AULIEF
- Manufacturer
- China Gel Inc
- Category
- Drug — Topical OTC Pain Relief
- Affected units
- 3,458
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: a) B136HN
- Exp 05/2021
- b) B136HN
- c) B136HN
UPCs (3)
- 687806300031
- 687806300079
- 687806300161
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by China Gel Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · China Gel Inc
See all →- HighChina-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination
FDA (Drugs) · 2021-09-08
- HighChina-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination
FDA (Drugs) · 2021-09-08
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08
Similar recalls
- SevereFDA Recalls X-Jow Pain Gel Due to Potential Bacterial Contamination
FDA (Drugs) · 2018-06-20
- ModerateUS Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateMenthol pain relief gel recalled over manufacturing practice deviations
FDA (Drugs) · 2025-12-03
- HighPain Wizard Topical Pain Relief Recalled for Out-of-Specification Active Ingredient
FDA (Drugs) · 2024-06-05
- CriticalFDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination
FDA (Drugs) · 2024-05-01
- ModerateQuality Choice menthol cough drops recalled after facility inspection findings
FDA (Drugs) · 2026-04-22