CLASS II Drug recall · Reported 30 Aug 2023 · FDA Enforcement Report
Helix Pain Relieving Cream (Menthol 7.4%) recalled
Parker Laboratories is recalling Helix Pain Relieving Cream (Menthol 7.4%), distributed nationwide in the US. The recall was initiated on 2 Aug 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1090-2023
- FDA event ID
- 92786
- Recalling firm
- Parker Laboratories, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2023
- FDA classified
- 18 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Aug 2023 | Recall initiated by company | |
| 18 Aug 2023 | Classified by FDA | +16 days |
| 30 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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 with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004
Where it was distributed
Nationwide within the United States, Singapore, Korea and Hong Kong
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
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, Exp. Date 4/29/2024, A0822004, Exp. Date 7/27/2025, d) C0222001, Exp. Date 6/30/2023, C0521003, Exp. Date 4/29/2023, C0822005, Exp. Date 7/27/2024, e)C0721019, Exp. Date 6/30/2024, f) C0521001, Exp. Date 4/29/2024, C0721022, Exp. Date 6/30/2024, C0822006, Exp. Date 7/27/2025, g) C0323006, C0821022, C0922006, Exp. Date 4/29/2024, C1221003, Exp. Date 4/09/2024
Where was it sold?
Nationwide within the United States, Singapore, Korea and Hong Kong
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 92786More recalls from Parker Laboratories
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Redux Electrolyte Creme, Product recalled by Parker Laboratories | Parker Laboratories | Other | Nationwide |
| Device | CLASS II | Tensive Conductive Adhesive Gel, Product recalled by Parker Laboratories | Parker Laboratories | Packaging Defects | 10 states |
| Drug | CLASS II | Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%) recalled | Parker Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Helix CBD Clinical Cream (Menthol 7.4%) recalled by Parker Laboratories | Parker Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Helix CBD Therapy Cream (Menthol 7.4%) recalled by Parker Laboratories | Parker Laboratories | Manufacturing (CGMP) Deviations | Nationwide |