Helix Pain Relief Cream (Parker Labs) – CGMP Manufacturing Issues (2023)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004
Brand
Parker Laboratories, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Parker Laboratories, Inc. is recalling Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz due to CGMP Deviations. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026