The Recall Desk

Hazard

Unapproved Drug recalls

547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
547
Critical
146
Severe
195
Most recent
2026-08-19

Of the 547 unapproved drug recalls we have scored against our rubric, 146 (27%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 195 (36%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved drug recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

401–425 of 547

  • SevereFDA (Food)·F-2956-2015·2015-08-19

    FDA Recalls Maxam Products for Unapproved Drug Claims

    James G. Cole, Inc. is recalling all Maxam brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.

    Product
    ALL MAXAM PRODUCTS: The Maxam product is used orally in spray form and bears the Maxam label. ********The List of MAXAM products********************************************** AD Nutritional Support for a Positive Outlook; AFX Nutritional Support for Healthy Cellular
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2957-2015·2015-08-19

    ASN Dietary Supplements Recalled for Unapproved Drug Claims

    James G. Cole, Inc. is recalling all ASN brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.

    Product
    ALL ASN products: The ASN products are in capsule or powdered form and bear the ASN label. *********the List of ASN products***************************** AFINITY WHEY PROTEIN; DHEA; HUMAGRO Homeopathic Growth Hormone 4c; PHYTOBOL; TESTRX; TRIBESTRONE II;
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0977-2015·2015-05-13

    FDA Recalls EDGE Weight Release Capsules Containing Unapproved Drugs

    Detox Transforms is recalling EDGE Amplified Weight Release capsules because the product contains undeclared phenolphthalein and fluoxetine, making it an unapproved drug.

    Product
    EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0986-2015·2015-05-13

    FDA Recalls Unapproved Anabolic Steroid Product HALO-70 MEGA MASS BUILDER

    The FDA is recalling HALO-70 MEGA MASS BUILDER capsules because they contain an unapproved synthetic hormone ingredient, making them unapproved new drugs.

    Product
    HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0979-2015·2015-05-13

    AMPD GOLD Bee Pollen Recalled for Undeclared Sildenafil

    Detox Transforms is recalling AMPD GOLD Bee Pollen capsules because they contain undeclared sildenafil, making them unapproved drugs.

    Product
    AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0989-2015·2015-05-13

    FDA Recalls Unapproved Anabolic Steroid Supplements from Anabolic Science Labs

    Anabolic Science Labs is recalling SWOLL-250 Super Mass Builder Quad Stack capsules because they contain unapproved synthetic hormone ingredients.

    Product
    SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0988-2015·2015-05-13

    FDA Recalls Estrastain Pro-Anabolic Mass and Hardening Complex Capsules

    Anabolic Science Labs LLC is recalling Estrastain Pro-Anabolic Mass and Hardening Complex capsules because they contain unapproved synthetic hormone ingredients.

    Product
    ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0978-2015·2015-05-13

    Detox Transforms Recalls iNDiGO Capsules Containing Undeclared Phenolphthalein

    Detox Transforms is recalling iNDiGO capsules because they contain undeclared phenolphthalein, making the product an unapproved drug.

    Product
    iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0981-2015·2015-05-13

    FDA Recalls iNSANE Bee Pollen Capsules Containing Unapproved Drugs

    The FDA is recalling iNSANE Bee Pollen capsules because they contain undeclared phenolphthalein and fluoxetine, making them unapproved drugs.

    Product
    iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0985-2015·2015-05-13

    FDA Recalls M14-Ment Advanced Mass Builder for Unapproved Steroid Ingredient

    The FDA is recalling M14-Ment Advanced Mass Builder capsules because they contain an unapproved synthetic hormone ingredient, making them unapproved new drugs.

    Product
    M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0980-2015·2015-05-13

    BtRiM Max capsules recalled for undeclared phenolphthalein

    Detox Transforms is recalling BtRiM Max capsules because they contain undeclared phenolphthalein, making the product an unapproved drug.

    Product
    BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0984-2015·2015-05-13

    FDA Recalls M1-Alpha Labs Mega Mass Builder for Unapproved Steroid Ingredient

    The FDA is recalling M1-Alpha Labs Mega Mass Builder capsules because they contain an unapproved synthetic hormone ingredient, making them unapproved new drugs.

    Product
    M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0990-2015·2015-05-13

    FDA Recalls Professional Formexx Black Due to Unapproved Steroid Ingredient

    Anabolic Science Labs is recalling Professional Formexx Black capsules because they contain an unapproved synthetic hormone ingredient.

    Product
    PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0987-2015·2015-05-13

    FDA Recalls 7-Ment Alpha Advanced Mass Builder for Unapproved Steroid Ingredient

    The FDA is recalling 7-Ment Alpha Advanced Mass Builder capsules because they contain an unapproved synthetic hormone ingredient.

    Product
    7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0329-2015·2015-01-07

    Ginseng Kianpi Pill Recalled for Undeclared FDA-Approved Drugs

    One and Zen is recalling Ginseng Kianpi Pill capsules because FDA analysis found undeclared dexamethasone and cyproheptadine, making the product an unapproved drug.

    Product
    GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2015·2014-12-31

    Chaotic Labz Recalls MAYHEM Capsules Containing Undeclared Prescription Drugs

    Chaotic Labz is recalling MAYHEM capsules because FDA analysis found undeclared dexamethasone and cyproheptadine, making the product an unapproved drug.

    Product
    MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1613-2014·2014-10-08

    Black Ant capsules recalled for undeclared sildenafil

    Eugene Oregon, Inc. is recalling Black Ant capsules because FDA testing found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.

    Product
    Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
    Category
    Drug
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-1614-2014·2014-10-08

    MOJO RISEN Recalled for Undeclared Sildenafil and Lack of Approval

    Eugene Oregon, Inc. is recalling MOJO RISEN because FDA testing found undeclared sildenafil and the product was marketed without an approved NDA or ANDA.

    Product
    MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
    Category
    Drug
    Distribution
    11 states
  • CriticalFDA (Drugs)·D1612-2014·2014-10-08

    African Black Ant capsules recalled for undeclared sildenafil

    Eugene Oregon, Inc. is recalling African Black Ant capsules because FDA laboratory analyses found undeclared sildenafil. The product was marketed without an approved NDA/ANDA.

    Product
    AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
    Category
    Drug
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-1596-2014·2014-09-24

    African Black Ant supplement recalled for undeclared sildenafil

    Nova Products, Inc. is voluntarily recalling African Black Ant capsules because FDA testing found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.

    Product
    AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1600-2014·2014-09-24

    Nova Products Recalls Xzen 1200 Due to Undeclared Erectile Dysfunction Ingredients

    Nova Products, Inc. is voluntarily recalling Xzen 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil, active ingredients in erectile dysfunction drugs.

    Product
    Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1599-2014·2014-09-24

    XZEN Platinum Recalled for Undeclared Erectile Dysfunction Drug Ingredients

    Nova Products, Inc. is voluntarily recalling XZEN Platinum capsules because FDA analysis found undeclared sildenafil and tadalafil.

    Product
    XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1598-2014·2014-09-24

    XZEN GOLD Recalled for Undeclared Erectile Dysfunction Drug Ingredients

    Nova Products, Inc. is voluntarily recalling XZEN GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.

    Product
    XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1602-2014·2014-09-24

    XZONE GOLD recalled for undeclared erectile dysfunction drug ingredients

    Nova Products, Inc. is voluntarily recalling XZONE GOLD capsules because FDA testing found undeclared sildenafil and tadalafil.

    Product
    XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2014·2014-09-24

    XZone 1200 Recalled for Undeclared Erectile Dysfunction Ingredients

    Nova Products, Inc. is voluntarily recalling XZone 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil.

    Product
    Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
    Category
    Drug
    Distribution
    Distributed nationwide