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USPlabs

OxyElite Pro

Serving
1 Capsule(s)
Per container
90
Form
capsule-unknown
DSLD
238967
Formula hash
78589eda3424
Brand context
USPlabs
CA
Catalog
140
products
With avoid flag
20
products
FDA recalls
7
history
CAERS
6
reports
Avoid-flaggedObjective label signals
Flagged excipients
3
1 avoid · 2 caution
FDA recalls
7
7 Class I / II
CAERS reports
4
FDA consumer events
Certifications
0
none recorded
1 avoid-level excipient · Every flag below links to the authority's published citation.

Supplement Facts

3 active ingredients
IngredientAmount% DV
Proprietary Blend
Proprietary Blend (Combination)other
119.5 mg—
Caffeine
herbUNII · 3G6A5W338E
100 mg—
2-Aminoisoheptane HCl
Dimethylhexylamine (DMHA)herb
100 mg—
Flagged excipients

3 flagged · authority citations

  • ● AVOIDTitanium Dioxide
    color

    Banned in EU food products effective 2022-08 (Commission Regulation (EU) 2022/63) following EFSA Panel opinion that a safe daily intake could not be established due to genotoxicity concerns. Still GRAS in the US under 21 CFR 73.575 but EU position is stricter.

    eur-lex.europa.eu →efsa.europa.eu →ecfr.gov →
  • ◐ CAUTIONFD&C Red #3
    color

    FDA revoked food/ingested-drug color additive approval for FD&C Red 3 in January 2025 (Docket FDA-2022-C-2886). Manufacturers have until January 2027 (foods) / January 2028 (ingested drugs) to reformulate.

    fda.gov →federalregister.gov →
  • ◐ CAUTIONFD&C Blue #1
    color

    EU requires 'attention in children' warning per Commission Regulation 1333/2008 Annex III. Limited to specific food categories; capsule-shell use permitted with restrictions.

    eur-lex.europa.eu →
Recall history

7 FDA recalls

  1. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
  2. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
  3. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) RASPBERRY LEMONADE Manufactured for USPlabs, LLC (Dallas, TX 75220)

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
  4. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GREEN APPLE Manufactured for USPlabs, LLC (Dallas, TX 75220)

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
  5. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM Manufactured for USPlabs, LLC (Dallas, TX 75220)

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
  6. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220)

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
  7. Class I2013-11-09brand-level

    USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.

    Reason: USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

    FDA record →
FDA CAERS · adverse event context
4
consumer-submitted adverse event reports filed with the FDA CFSAN Adverse Event Reporting System mentioning this product or its brand.

CAERS reports are unverified consumer submissions — not adjudicated causality. Large well-known brands accumulate proportionally more reports simply due to broader use. About CAERS →

Other ingredients

Sodium Starch Glycolate · Gelatin · Vegetable Stearate · Silicon Dioxide · Dicalcium Phosphate