CLASS II Food recall · Reported 8 Apr 2015 · FDA Enforcement Report
Saw Palmetto Plus recalled by Health One Pharmaceuticals
Health One Pharmaceuticals is recalling Saw Palmetto Plus, distributed nationwide in the US. The recall was initiated on 4 Feb 2015 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-1635-2015
- FDA event ID
- 70344
- Recalling firm
- Health One Pharmaceuticals, City Of Industry, CA
- Brand
- Saw Palmetto
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2015
- FDA classified
- 30 Mar 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Product category
- Dietary Supplements
Timeline
| 4 Feb 2015 | Recall initiated by company | |
| 30 Mar 2015 | Classified by FDA | +54 days |
| 8 Apr 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Health One Pharmaceuticals is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
Product as listed by the FDA
Saw Palmetto Plus, 60 capsules
Where it was distributed
Nationwide in US: CA, TN, WA, ID, and worldwide: Hong Kong, Vietnam, China, Singapore
Questions about this recall
Is Saw Palmetto Plus recalled?
Yes. Health One Pharmaceuticals recalled Saw Palmetto Plus on 4 Feb 2015. The recall is Class II and its status is Terminated. Recall number F-1635-2015.
Why was it recalled?
Health One Pharmaceuticals is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
Which lots are affected?
9203
Where was it sold?
Nationwide in US: CA, TN, WA, ID, and worldwide: Hong Kong, Vietnam, China, Singapore
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Health One Pharmaceuticals
All 147| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Lecithin recalled by Health One PharmaceuticalsLecithin | Health One Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Food | CLASS II | Lecithin recalled by Health One PharmaceuticalsLecithin | Health One Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Food | CLASS II | Brainy Formula recalled by Health One PharmaceuticalsBrainy | Health One Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Food | CLASS II | HairVive, 400mg recalled by Health One PharmaceuticalsHairVive | Health One Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Food | CLASS II | Nu Kang Bao recalled by Health One PharmaceuticalsNu Kang | Health One Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Dietary Supplements recalls
All 733| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | ANNOUNCED | Niwali Tejocote Capsules and Pieces recalled by Global MixNiwali | Global Mix | Foreign Material | Nationwide |
| Food | CLASS I | Addall XR Shot, liquid dietary supplement recalled by ZMB EnterprisesAddall XR | ZMB Enterprises | Hidden Drug Ingredients | CA |
| Food | CLASS II | Super Skin; Dietary Supplement;, 2 per day recalled by Mellish IslandMellish Island | Mellish Island | Other | Nationwide |
| Food | CLASS I | Modern Warrior Ready, Dietary Supplement recalledModern Warrior | Modern Warrior Life | Hidden Drug Ingredients | Nationwide |
| Food | CLASS II | Vista MAX; Dietary Supplement Serving Size recalled by Provision HealthVista MAX | Provision Health | Undeclared Allergens | CA |