The Recall Desk

Hazard

Undeclared Drug recalls

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

What the numbers show

Total
74
Critical
63
Severe
9
Most recent
2024-05-01

Of the 74 undeclared drug recalls we have scored against our rubric, 63 (85%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (12%) 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 undeclared 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.

51–74 of 74

  • CriticalFDA (Drugs)·D-0880-2016·2016-06-01

    FDA Recalls Weight Loss Capsules Containing Undeclared Sibutramine and Phenolphthalein

    Lucy's Weight Loss is recalling Shorts on The Beach Strong Formula capsules nationwide because they contain undeclared sibutramine and phenolphthalein.

    Product
    Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0722-2016·2016-02-24

    Fit Firm and Fabulous Recalls Ultimate Herbal Slimcap Capsules

    Fit Firm and Fabulous is recalling Ultimate Herbal Slimcap Capsules because they contain undeclared sibutramine, a controlled substance removed from the U.S. market for safety reasons.

    Product
    Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0675-2016·2016-02-24

    Inaffit Recalls Natureal Burn Fat Nature Due to Undeclared Sibutramine

    Inaffit, LLC is recalling Natureal Burn Fat Nature capsules because the product contains undeclared sibutramine and was marketed without an approved NDA or ANDA.

    Product
    NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0296-2016·2015-11-25

    LiDa DAIDAIHUA capsules recalled for undeclared sibutramine and phenolphthalein

    Blue Square Market, Inc. is recalling LiDa DAIDAIHUA capsules nationwide because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA or ANDA.

    Product
    LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0991-2015·2015-05-13

    Ultra ZX Dietary Supplement Recalled for Undeclared Sibutramine and Phenolphthalein

    Ultra ZX Labs is recalling Ultra ZX dietary supplements because FDA testing found undeclared sibutramine and phenolphthalein. The product was marketed without an approved NDA or ANDA.

    Product
    ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
    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-1597-2014·2014-09-24

    Nova Products Recalls Black Ant for Undeclared Sildenafil

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

    Product
    Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA.,
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1594-2014·2014-09-24

    Dietary Supplement Recalled for Undeclared Sibutramine and Lack of Approval

    Nature's Universe is recalling ThinoGenics dietary supplements because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1535-2014·2014-08-20

    Super ARTHGOLD Recalled for Undeclared Prescription Drugs

    Super ARTHGOLD dietary supplement is being recalled because it contains undeclared prescription drugs and was marketed without FDA approval.

    Product
    Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1367-2014·2014-06-18

    Bella Vi BTrim Ultimate Boost Recalled for Undeclared Dangerous Ingredients

    Pure Edge Nutrition is recalling Bella Vi BTrim Ultimate Boost capsules because they contain undeclared sibutramine and phenolphthalein.

    Product
    Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1370-2014·2014-06-18

    Bella Vi AMP'D UP Weight Loss Supplement Recalled for Undeclared Drugs

    Pure Edge Nutrition is recalling Bella Vi AMP'D UP weight loss capsules because they contain undeclared sibutramine and phenolphthalein.

    Product
    Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1331-2014·2014-05-28

    Herbal Give Care Recalls Esbelder Siloutte Supplement for Undeclared Sibutramine

    Herbal Give Care is recalling Esbelder Siloutte dietary supplements because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1332-2014·2014-05-28

    Esbelder Man Herbal Blend Recalled for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelder Man Herbal Blend because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1329-2014·2014-05-28

    Esbelin Siloutte Mezcal Herbal Recalled for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelin Siloutte Mezcal Herbal because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1333-2014·2014-05-28

    Herbal Give Care Recalls Esbelder Fem Supplement for Undeclared Sibutramine

    Herbal Give Care Llc is recalling Esbelder Fem Mezcla con L-Carnitina because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1330-2014·2014-05-28

    Herbal Tea Recalled for Undeclared Sibutramine and Related Compounds

    Herbal Give Care Llc is recalling Esbelin Siloutte Te herbal tea because it contains undeclared sibutramine and related compounds, making it an unapproved new drug.

    Product
    Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1249-2014·2014-04-30

    JaDera Weight Loss Supplement Recalled for Undeclared Sibutramine

    Dolphin Intertrade Corporation is recalling JaDera weight loss capsules because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

    Product
    JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1232-2014·2014-04-23

    Lidiy capsules recalled for undeclared sibutramine and lack of FDA approval

    B @ B Trade Inc. is recalling Lidiy capsules because the dietary supplement was marketed without FDA approval and contains undeclared sibutramine.

    Product
    Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1231-2014·2014-04-23

    Slim Fortune capsules recalled for undeclared sibutramine

    B @ B Trade Inc. is recalling Slim Fortune capsules because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1223-2014·2014-04-16

    FDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil

    The FDA is recalling Vicerex male sexual enhancer capsules because laboratory analysis found undeclared tadalafil, an unapproved drug ingredient.

    Product
    Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1224-2014·2014-04-16

    FDA Recalls Black Ant Supplement Containing Undeclared Sildenafil

    The FDA is recalling Black Ant dietary supplements because laboratory analysis found they contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction.

    Product
    Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 402
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1154-2014·2014-03-19

    CTV Best Group Recalls BEST Slim Weight Loss Pills

    CTV Best Group is recalling BEST Slim weight loss pills because they contain the undeclared drug sibutramine, making them unapproved new drugs.

    Product
    BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1067-2014·2014-02-12

    Health & Beyond Tranquility Supplement Recalled for Unapproved Prescription Drugs

    Health & Beyond is recalling Tranquility dietary supplements because they contain unapproved prescription drugs, Doxepin and Chlorpromazine.

    Product
    HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.
    Category
    Drug
    Distribution
    7 states