US Pharmaceuticals Recalls Wonder Freeze Pain Gel Due to Water Quality Issues
US Pharmaceuticals is recalling Wonder Freeze Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves manufacturing deviations in water quality rather than a confirmed high-risk pathogen or injury report, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
US Pharmaceuticals Inc. is recalling Wonder Freeze Pain Relieving Gel with ILEX, Menthol 5%. The recall affects 147 cases of the product in 3 oz, 4 oz, and 16 oz packages, which were distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water utilized in the manufacturing process yielded out-of-specification results for either total microbial count or total organic carbon.
Consumers who have purchased this product should check their lot numbers and expiration dates against the specific lots identified in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 147
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 (5)
- Lot # a) 21J18
- EXP 07/2021 b) 42H18
- EXP 06/2021
- c) 32H18
- EXP 6/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by US Pharmaceuticals 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 18 products in this recall →Related recalls
Same manufacturer · US Pharmaceuticals Inc.
See all →- ModerateCVS Healing Ointment Recalled for Low Weight Fill Tubes
FDA (Drugs) · 2020-12-09
- ModerateUS Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateUS Pharmaceuticals Recalls Intensive Healing Eczema Lotion for Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateCVS Health Glycerin Suppositories Recalled for Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateUS Pharmaceuticals Recalls Soothe&Cool Protect Moisture Guard Skin Protectant
FDA (Drugs) · 2019-08-21
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereIdeaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels
FDA (Drugs) · 2018-05-30
- SevereSuperior Pain & Itch Relief Lidocaine Gel Recalled for Contamination
FDA (Drugs) · 2019-09-25
- SevereIdeaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels
FDA (Drugs) · 2018-05-30
- ModerateUS Pharmaceuticals Recalls Hydrocortisone Cream Due to Microbial Contamination
FDA (Drugs) · 2019-02-13
- HighGolden Tiger Pain Relief Cream Recalled for Out-of-Specification Ingredients
FDA (Drugs) · 2024-06-05
- ModerateFDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse
FDA (Drugs) · 2022-06-15