CLASS III Food recall · Reported 19 May 2021 · FDA Enforcement Report
Btrex Plus, Dietary Supplement 100 Caplets recalled
Lopez Gonzalez Santana is recalling Btrex Plus, Dietary Supplement 100 Caplets, distributed in Puerto Rico. The recall was initiated on 20 Apr 2021 and the FDA has classified it as Class III.
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-0484-2021
- FDA event ID
- 87758
- Recalling firm
- Lopez Gonzalez Santana, Rio Piedras, PR
- Brand
- Btrex Plus
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Apr 2021
- FDA classified
- 7 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Product category
- Dietary Supplements
Timeline
| 20 Apr 2021 | Recall initiated by company | |
| 7 May 2021 | Classified by FDA | +17 days |
| 19 May 2021 | 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 Deviation: Presence of damaged tablets
Product as listed by the FDA
BTREX PLUS, Dietary Supplement 100 Caplets
Where it was distributed
Domestic distribution only-PR
Questions about this recall
Why was it recalled?
cGMP Deviation: Presence of damaged tablets
Which lots are affected?
Lot # 33277 Exp date:12/22
Where was it sold?
Domestic distribution only-PR
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Lopez Gonzalez Santana
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Btrex Plus, Dietary Supplement 2 caplets recalledBtrex Plus | Lopez Gonzalez Santana | Manufacturing (CGMP) Deviations | PR |
| Food | CLASS III | Btrex Plus, Dietary Supplement 100 Caplets recalledBtrex Plus | Lopez Gonzalez Santana | Manufacturing (CGMP) Deviations | PR |
| Food | CLASS III | Btrex Plus, Dietary Supplement 100 Caplets recalledBtrex Plus | Lopez Gonzalez Santana | Manufacturing (CGMP) Deviations | PR |
| Food | CLASS III | Btrex Plus, Dietary Supplement 2 Caplets recalledBtrex Plus | Lopez Gonzalez Santana | Manufacturing (CGMP) Deviations | PR |
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 |