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.

251–275 of 547

  • SevereFDA (Drugs)·D-0347-2018·2018-02-21

    FDA Recalls Unapproved Limbrel500 Capsules Marketed Without Approval

    Primus Pharmaceuticals is recalling Limbrel500 capsules because they were marketed without FDA approval, meaning their safety and efficacy have not been established.

    Product
    Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2018·2018-02-21

    Primus Pharmaceuticals Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide

    Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2018·2018-02-21

    FDA Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide

    Primus Pharmaceuticals is recalling 7,826 bottles of Limbrel (flavocoxid 250 mg) capsules because the product was marketed without an approved NDA or ANDA.

    Product
    Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2018·2018-02-14

    Flawless Beauty LLC Recalls Ling Zhi Capsules for Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules because they were marketed without an approved NDA/ANDA, constituting misbranding and unapproved new drugs.

    Product
    Ling Zhi capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Glutathione Whitening Injection Kits

    Flawless Beauty LLC is voluntarily recalling all lots of TAD Glutathione Whitening Kits because the products were marketed without FDA approval.

    Product
    TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Glutathione Injectable Products Nationwide

    Flawless Beauty LLC is voluntarily recalling all lots of Tationil Glutathione and other products sold in kits. The recall is due to misbranding and the sale of unapproved new drugs under a court order.

    Product
    Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0326-2018·2018-02-14

    Flawless Beauty Recalls Tatiomax Glutathione Whitening Kits Nationwide

    Flawless Beauty LLC is voluntarily recalling Tatiomax Glutathione Whitening kits nationwide because the products were marketed without FDA approval.

    Product
    Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Saluta Glutathione Whitening Kits Nationwide

    Flawless Beauty LLC is voluntarily recalling all lots of Saluta Glutathione Whitening kits nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0332-2018·2018-02-14

    Flawless Beauty Recalls Sterilized Water for Injections Due to Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections sold in the U.S. because the products were marketed without FDA approval.

    Product
    Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0329-2018·2018-02-14

    Flawless Beauty Recalls Unapproved Laennec Placenta Extract Injections

    Flawless Beauty LLC is voluntarily recalling Laennec INJ placenta extract vials because they were marketed without FDA approval.

    Product
    Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2018·2018-02-14

    Flawless Beauty Recalls Relumins Advanced Glutathione Kits Nationwide

    Flawless Beauty LLC is voluntarily recalling all lots of Relumins Advanced Glutathione kits nationwide because the products were marketed without FDA approval.

    Product
    Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2018·2018-02-14

    Flawless Beauty Recalls Laroscorbine Platinum Vitamin C Due to Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Laroscorbine Platinum Vitamin C products because they were marketed without an approved NDA or ANDA.

    Product
    Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0325-2018·2018-02-14

    Flawless Beauty Recalls Relumins Vitamin C Ampules for Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules because they were marketed without an approved NDA or ANDA.

    Product
    Relumins Vitamin C Solvent ampules
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0247-2018·2018-02-07

    Blue Pearl Capsules Recalled for Undeclared Sildenafil

    Blue Fusion Natural is recalling Blue Pearl capsules because FDA analysis found undeclared sildenafil, an unapproved drug for erectile dysfunction.

    Product
    BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0558-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.

    Product
    LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0563-2018·2018-02-07

    FDA Recalls Unapproved Zhonghua Niubian Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Zhonghua Niubian tablets found to contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0566-2018·2018-02-07

    Unapproved herbal capsules containing sildenafil recalled by FDA

    A&H Focal Inc. is recalling HU HU SHENG WEI capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0552-2018·2018-02-07

    FDA Recalls Unapproved Black Ant Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Black Ant capsules found to contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0572-2018·2018-02-07

    FDA Recalls Unapproved Tiger King Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Tiger King tablets because they contain sildenafil, an unapproved drug for erectile dysfunction, and lack FDA approval.

    Product
    Tiger King tablets, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0567-2018·2018-02-07

    Unapproved Yanshijiaonang Capsules Containing Sildenafil Recalled by FDA

    A&H Focal Inc. is recalling Yanshijiaonang capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0559-2018·2018-02-07

    FDA Recalls Unapproved Gold Vigra Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Gold Vigra capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0571-2018·2018-02-07

    FDA Recalls MACA Gold Tablets Containing Unapproved Sildenafil

    A&H Focal Inc. is recalling MACA gold tablets sold in New York and New Jersey because they contain sildenafil, an unapproved drug.

    Product
    MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0554-2018·2018-02-07

    FDA Recalls Unapproved Miraculous Evil Root Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Miraculous Evil Root capsules because FDA analysis found they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states