The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1090-2023·Announced 2023-08-30

Helix Pain Relieving Cream recalled nationwide for manufacturing process violations

Parker Laboratories is recalling Helix Pain Relieving Cream due to manufacturing process deviations. The voluntary recall affects multiple package sizes 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 due to manufacturing process violations (CGMP deviations), voluntarily initiated by the manufacturer. No illnesses, injuries, or hospitalizations are reported. FDA Class II recalls without hospitalization reports typically score as Moderate severity per the rubric.

Plain-English summary

Parker Laboratories, Inc. recalled Helix Pain Relieving Cream (Menthol 7.4%) due to manufacturing process deviations. The product is available in multiple package sizes: 5 gram pouches, 3 fluid ounce roll-ons, 4 fluid ounce tubes, 12 fluid ounce pump bottles, 32 fluid ounce pump bottles, 1 gallon pump bottles, and starter kits.

The recall was initiated because the manufacturer identified deviations from Current Good Manufacturing Practice (CGMP) standards during production. These manufacturing process violations can affect product quality and safety.

The recalled product was distributed nationwide within the United States, as well as to Singapore, Korea, and Hong Kong. Approximately 250 units were involved in this recall. The recall was initiated on August 2, 2023, and was terminated on June 3, 2024.

Consumers who have purchased Helix Pain Relieving Cream with the affected lot codes should stop using the product. Refer to the FDA or contact Parker Laboratories for information about product replacement or return options.

The recalled product

Product
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon…
Manufacturer
Parker Laboratories, Inc.
Category
Drug — Topical Pain Relief
Hazard
Affected units
250

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 (20)

  • a) J0721010
  • Exp. Date 6/30/2024
  • J1022017
  • Exp. Date 10/27/2025
  • b) A0521002
  • Exp. Date 4/29/2024
  • c) A0322006
  • Exp. Date 3/2/2025
  • A0323004
  • Exp. Date 2/24/2026
  • A0422005
  • Exp. Date 3/14/2025
  • A0521001
  • A0822004
  • Exp. Date 7/27/2025
  • d) C0222001
  • Exp. Date 6/30/2023
  • C0521003
  • Exp. Date 4/29/2023
  • C0822005

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.

See all 5 products in this recall →

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