Medications & Supplements/Topical Products

Protex and Helix Hand Sanitizers and Pain Creams Recalled for Manufacturing

Agency Publication Date: August 18, 2023

Summary

Parker Laboratories, Inc. is recalling 357 units of Protex Foaming Hand Sanitizer and several Helix-branded pain relief creams, including Helix Pain Relieving Cream, Tri-Active Therapy Cream, CBD Therapy Cream, and CBD Clinical Cream. The recall was initiated due to manufacturing issues (CGMP deviations) that were identified at the facility. These products were sold in various sizes ranging from individual packets to one-gallon containers and were distributed nationwide and internationally to Singapore, Korea, and Hong Kong. No injuries or incidents have been reported to date.

Risk

The manufacturing deviations mean the products may not have been produced according to safety and quality standards, which could potentially impact the effectiveness of the medication or lead to unexpected reactions when applied to the skin.

What You Should Do

This recall affects Protex Foaming Hand Sanitizer and various Helix pain relief creams (Pain Relieving, Tri-Active, CBD Therapy, and CBD Clinical) sold in containers ranging from 3-gram packets to 1-gallon bottles.
Identify if your product is affected by checking the lot numbers and expiration dates on the packaging. Affected codes include lots G0323002, G1122001, J0721010, J1022017, A0521002, and A0322006. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Parker Laboratories, Inc. for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%)

Variants: 2 fl oz/60 mL Pump bottle, 18 fl oz/550 mL Pump bottle

Lot Numbers:

G0323002 (Exp. Date 3/1/2025)

G1122001 (Exp. Date 11/15/2024)

NDC:

30775-040-02

30775-040-18

Recall #: D-1089-2023

Product: Helix Pain Relieving Cream (Menthol 7.4%)

Variants: 5 gm pouch, 3 fl. oz. roll-on, 4 fl. oz. tube, 12 fl oz pump bottle, 32 fl. oz. pump bottle, 1 U.S. gallon with pump, Starter Kit

Lot Numbers:

J0721010 (Exp. Date 6/30/2024)

J1022017 (Exp. Date 10/27/2025)

A0521002 (Exp. Date 4/29/2024)

A0322006 (Exp. Date 3/2/2025)

A0323004 (Exp. Date 2/24/2026)

A0422005 (Exp. Date 3/14/2025)

A0521001 (Exp. Date 4/29/2024)

A0822004 (Exp. Date 7/27/2025)

C0222001 (Exp. Date 6/30/2023)

C0521003 (Exp. Date 4/29/2023)

C0822005 (Exp. Date 7/27/2024)

C0721019 (Exp. Date 6/30/2024)

C0521001 (Exp. Date 4/29/2024)

C0721022 (Exp. Date 6/30/2024)

C0822006 (Exp. Date 7/27/2025)

C0323006

C0821022

C0922006 (Exp. Date 4/29/2024)

C1221003 (Exp. Date 4/09/2024)

NDC:

30775-051-01

30775-051-03

30775-051-04

30775-051-12

30775-051-32

30775-051-50

30775-051-95

Recall #: D-1090-2023

Product: Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%)

Variants: 3 fl. oz. roll-on, 4 fl. oz. tube

Lot Numbers:

A1221010 (Exp. Date 12/9/2023)

A1221011 (Exp. Date 12/9/2023)

NDC:

30775-052-03

30775-052-04

Recall #: D-1091-2023

Product: Helix CBD Therapy Cream (Menthol 7.4%)

Variants: 3 g pouch, 2 fl. oz. tube, 4 fl. oz. tube

Lot Numbers:

J1121010 (Exp. Date 12/16/2023)

A0921006 (Exp. Date 8/16/2023)

A0921007 (Exp. Date 8/16/2023)

NDC:

30775-053-01

30775-053-02

30775-053-04

Recall #: D-1092-2023

Product: Helix CBD Clinical Cream (Menthol 7.4%)

Variants: 3 gm pouch, 2 fl. oz. tube, 4 fl. oz. tube

Lot Numbers:

J1121011 (Exp. Date 12/21/2023)

A0921009 (Exp. Date 8/18/2023)

A0921008 (Exp. Date 8/18/2023)

NDC:

30775-054-01

30775-054-02

30775-054-04

Recall #: D-1093-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92786

Status: Resolved

Manufacturer: Parker Laboratories, Inc.

Sold By: Retailers nationwide; Specialty medical distributors

Manufactured In: United States

Units Affected: 5 products (9; 250; 8; 40; 50)

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 · 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.

Summary

What You Should Do

This recall affects Protex Foaming Hand Sanitizer and various Helix pain relief creams (Pain Relieving, Tri-Active, CBD Therapy, and CBD Clinical) sold in containers ranging from 3-gram packets to 1-gallon bottles.

Identify if your product is affected by checking the lot numbers and expiration dates on the packaging. Affected codes include lots G0323002, G1122001, J0721010, J1022017, A0521002, and A0322006. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Parker Laboratories, Inc. for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%)

Variants: 2 fl oz/60 mL Pump bottle, 18 fl oz/550 mL Pump bottle

Lot Numbers:

G0323002 (Exp. Date 3/1/2025)

G1122001 (Exp. Date 11/15/2024)

NDC:

30775-040-02

30775-040-18

Recall #: D-1089-2023

Product: Helix Pain Relieving Cream (Menthol 7.4%)

Variants: 5 gm pouch, 3 fl. oz. roll-on, 4 fl. oz. tube, 12 fl oz pump bottle, 32 fl. oz. pump bottle, 1 U.S. gallon with pump, Starter Kit

Lot Numbers:

J0721010 (Exp. Date 6/30/2024)

J1022017 (Exp. Date 10/27/2025)

A0521002 (Exp. Date 4/29/2024)

A0322006 (Exp. Date 3/2/2025)

A0323004 (Exp. Date 2/24/2026)

A0422005 (Exp. Date 3/14/2025)

A0521001 (Exp. Date 4/29/2024)

A0822004 (Exp. Date 7/27/2025)

C0222001 (Exp. Date 6/30/2023)

C0521003 (Exp. Date 4/29/2023)

C0822005 (Exp. Date 7/27/2024)

C0721019 (Exp. Date 6/30/2024)

C0521001 (Exp. Date 4/29/2024)

C0721022 (Exp. Date 6/30/2024)

C0822006 (Exp. Date 7/27/2025)

C0323006

C0821022

C0922006 (Exp. Date 4/29/2024)

C1221003 (Exp. Date 4/09/2024)

NDC:

30775-051-01

30775-051-03

30775-051-04

30775-051-12

30775-051-32

30775-051-50

30775-051-95

Recall #: D-1090-2023

Product: Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%)

Variants: 3 fl. oz. roll-on, 4 fl. oz. tube

Lot Numbers:

A1221010 (Exp. Date 12/9/2023)

A1221011 (Exp. Date 12/9/2023)

NDC:

30775-052-03

30775-052-04

Recall #: D-1091-2023

Product: Helix CBD Therapy Cream (Menthol 7.4%)

Variants: 3 g pouch, 2 fl. oz. tube, 4 fl. oz. tube

Lot Numbers:

J1121010 (Exp. Date 12/16/2023)

A0921006 (Exp. Date 8/16/2023)

A0921007 (Exp. Date 8/16/2023)

NDC:

30775-053-01

30775-053-02

30775-053-04

Recall #: D-1092-2023

Product: Helix CBD Clinical Cream (Menthol 7.4%)

Variants: 3 gm pouch, 2 fl. oz. tube, 4 fl. oz. tube

Lot Numbers:

J1121011 (Exp. Date 12/21/2023)

A0921009 (Exp. Date 8/18/2023)

A0921008 (Exp. Date 8/18/2023)

NDC:

30775-054-01

30775-054-02

30775-054-04

Recall #: D-1093-2023