Pigmentation treatment product recalled for manufacturing process deviations
Only Your Rx pigmentation product is being recalled due to manufacturing quality deviations in water systems used during production. The product was distributed in California only.
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 deviations with no reported illnesses or injuries. Per the severity rubric, Class II recalls without hospitalization reports and with theoretical rather than confirmed hazards typically receive a Moderate rating.
Plain-English summary
Only Your Rx Pigmentation Activator is being recalled. The product is manufactured by Generitech Corporation and was distributed in California. The affected lot number is 2400017 with an expiration date of April 30, 2026.
The FDA has issued this Class II recall due to Current Good Manufacturing Practice (CGMP) deviations identified in the water systems used during product manufacturing. No illnesses or injuries have been reported in connection with this product.
Consumers or healthcare professionals who possess this product should contact the manufacturer for instructions regarding return or disposal.
The recalled product
- Product
- 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.
- Manufacturer
- Generitech Corporation
- Category
- Drug — Topical Drug
- Hazard
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 (2)
- Lot #: 2400017
- Exp: 4/30/2026
Distribution
Distributed in 1 state:
Related recalls
Same hazard · manufacturing deviation
See all →- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
Similar recalls
- SevereSynergy Rx Custom Lightening Cream Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- LowAkorn Recalls Gabapentin Oral Solution Due to Unapproved Manufacturer
FDA (Drugs) · 2018-01-17
- ModerateAdvanced Pharma Recalls Gentamicin Sulfate for Latex Labeling Defect
FDA (Drugs) · 2017-05-31
- SevereSynergy Rx Recalls Gentle Bleaching Cream Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls Purified Water Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Brightening Cream Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22