The Recall Desk
ModerateFDA (Drugs)·D-1093-2023·Announced 2023-08-30

FDA Recalls Helix CBD Clinical Cream for Manufacturing Process Violations

Parker Laboratories is recalling Helix CBD Clinical Cream due to manufacturing process deviations. The FDA Class II recall affects batches distributed nationwide and internationally; consumers should discontinue use and contact the manufacturer.

What this means for you

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 due to manufacturing process deviations with no reported illnesses or injuries. The voluntary, precautionary recall fits the rubric criteria for moderate severity.

Plain-English summary

Parker Laboratories has recalled Helix CBD Clinical Cream (Menthol 7.4%) in multiple package sizes due to Good Manufacturing Practice (CGMP) deviations. The affected products include 3 gm pouches, 2 fl. oz. tubes, and 4 fl. oz. tubes with specific lot numbers: J1121011 (expiring 12/21/2023), A0921009 (expiring 8/18/2023), and A0921008 (expiring 8/18/2023).

The recall was initiated on August 2, 2023, after the FDA classified the issue as a Class II safety concern. Manufacturing deviations were identified during the agency's review of the product's production process. No illnesses or injuries have been reported in connection with this product.

The affected cream was distributed nationwide in the United States, as well as internationally to Singapore, Korea, and Hong Kong. Consumers who have purchased these products should stop using them and contact Parker Laboratories for return or disposal instructions.

This recall was initiated voluntarily by the manufacturer and terminated on June 3, 2024, once corrective manufacturing measures were completed.

The recalled product

Product
Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
Manufacturer
Parker Laboratories, Inc.
Category
Drug — Topical Cream
Hazard
  • manufacturing-deviation

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) J1121011
  • Exp. Date 12/21/2023
  • b) A0921009
  • Exp. Date 8/18/2023
  • c) A0921008

Distribution

Distributed nationwide across the United States.

Related recalls

Same category