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.

326–350 of 547

  • ModerateFDA (Drugs)·D-1352-2016·2016-07-20

    Peking Niu-Huang Chieh-Tu-Pien Tablets Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Peking Niu-Huang Chieh-Tu-Pien Tablets because they bear drug claims without FDA approval.

    Product
    PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1355-2016·2016-07-20

    Murray International Trading Recalls Farser Kai Yeung Pill for Unapproved Drug Claims

    Murray International Trading Co., Inc. is recalling Farser Kai Yeung Pill because it is marketed with drug claims without FDA approval.

    Product
    FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1358-2016·2016-07-20

    Murray International Recalls Unapproved Flucinonide Ointment Cream

    Murray International Trading Co., Inc. is recalling 97 boxes of FUQINGSONG RELIEF CREAM because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chine
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1350-2016·2016-07-20

    Murray International Recalls Tien Ma Tou Tong Wan Pills for Unapproved Drug Claims

    Murray International Trading Co. is recalling Tien Ma Tou Tong Wan pills because they bear drug claims despite being marketed as dietary supplements.

    Product
    Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1356-2016·2016-07-20

    Ping On Ointment Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Ping On Ointment because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1145-2016·2016-07-13

    Prime Capsules Recalled for Undeclared Sibutramine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling Prime Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.

    Product
    Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1142-2016·2016-07-13

    Jenesis Capsules Recalled for Undeclared Sibutramine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling Jenesis Capsules marketed as a dietary supplement because they contain undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.

    Product
    Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1141-2016·2016-07-13

    Bee Extremely Amazed LLC Recalls Infinity Capsules Tainted With Sibutramine

    Bee Extremely Amazed LLC is recalling Infinity Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.

    Product
    Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1150-2016·2016-07-13

    XCEL Advanced Capsules Recalled for Undeclared Phenolphthalein

    Bee Extremely Amazed LLC is recalling XCEL Advanced Capsules because they contain undeclared phenolphthalein, a withdrawn ingredient with carcinogenic concerns.

    Product
    XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2016·2016-06-15

    Methyldrene Original 25 Ephedra ECA Stack Recalled for Unapproved Salicylic Acid

    Novacare, LLC is recalling Methyldrene Original 25 Ephedra ECA Stack dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug.

    Product
    Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0910-2016·2016-06-08

    FDA Recalls Unapproved Ligandrol Supplements Sold Nationwide and in Brazil

    Invisiblu International LLC is recalling LGD-Xtreme capsules containing unapproved ligandrol because the product was marketed without an approved NDA or ANDA.

    Product
    LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0887-2016·2016-06-01

    FDA Recalls Stree Overlord Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Stree Overlord capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0878-2016·2016-06-01

    Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients

    Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0883-2016·2016-06-01

    Shorts on the Beach capsules recalled for undeclared dangerous ingredients

    Lucy's Weight Loss System is recalling Shorts on the Beach capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.

    Product
    Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0908-2016·2016-06-01

    Licorice Coughing Liquid Recalled for Undeclared Morphine

    Master Herbs is recalling Licorice Coughing Liquid because it contains undeclared morphine and was marketed without an approved NDA or ANDA.

    Product
    Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0882-2016·2016-06-01

    Pink Bikini capsules recalled for undeclared dangerous ingredients

    Lucy's Weight Loss System is recalling Pink Bikini capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.

    Product
    Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0877-2016·2016-06-01

    Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients

    Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0904-2016·2016-06-01

    Tiger King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Tiger King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0897-2016·2016-06-01

    Germany Niubian Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Germany Niubian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0900-2016·2016-06-01

    Hard Ten Days capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Hard Ten Days capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0879-2016·2016-06-01

    Pink Bikini Strong Formula capsules recalled for undeclared ingredients

    Lucy's Weight Loss System is recalling Pink Bikini Strong Formula capsules because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA/ANDA.

    Product
    Pink Bikini Strong Formula 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-0905-2016·2016-06-01

    FDA Recalls Samurai-X Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Samurai-X capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0888-2016·2016-06-01

    Weekend Prince capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Weekend Prince capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0895-2016·2016-06-01

    FDA Recalls Black Ant King for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Black Ant King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide