Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations
Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.
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: This is an FDA Class II recall initiated voluntarily by the manufacturer due to Current Good Manufacturing Practice deviations. No illnesses, injuries, or adverse events are reported in the source documentation. CGMP violations represent process-level compliance issues rather than confirmed contamination or defect, aligning with the Moderate severity classification for voluntary precautionary recalls.
Plain-English summary
Helix CBD Therapy Cream (Menthol 7.4%), manufactured by Parker Laboratories, Inc. of Fairfield, New Jersey, is the subject of this recall. The product is available in three package sizes: 3 g pouches, 2 fl. oz. tubes, and 4 fl. oz. tubes, each identified by specific NDC numbers.
Parker Laboratories voluntarily initiated this Class II recall on August 2, 2023, citing Current Good Manufacturing Practice (CGMP) deviations. The specific manufacturing deficiencies are not detailed in the recall documentation.
The affected products were distributed nationwide throughout the United States, as well as internationally to Singapore, Korea, and Hong Kong. Three specific lot numbers were recalled: J1121010 (expiring 12/16/2023), A0921006 (expiring 8/16/2023), and A0921007 (expiring 8/16/2023). The recall was terminated on June 3, 2024.
Consumers with this product should discontinue use and contact the manufacturer or the FDA for guidance on safe disposal or replacement options.
The recalled product
- Product
- Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
- Manufacturer
- Parker Laboratories, Inc.
- Category
- Drug — Topical Cream
- Hazard
- Affected units
- 40
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) J1121010
- Exp. Date 12/16/2023
- b) A0921006
- Exp. Date 8/16/2023
- c) A0921007
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Parker Laboratories, 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.
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