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.

301–325 of 547

  • CriticalFDA (Drugs)·D-1117-2017·2017-08-30

    CaverFlo Natural Herbal Coffee Recalled for Undeclared Sildenafil and Tadalafil

    The FDA is recalling CaverFlo Natural Herbal Coffee because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or ANDA.

    Product
    CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1096-2017·2017-08-23

    FDA Recalls Unapproved Caffeine Powder Marketed Without NDA Approval

    Global Marketing Enterprises is recalling 52.5 kg of unapproved caffeine powder marketed with stimulant claims and lacking adequate directions for use.

    Product
    Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0867-2017·2017-05-31

    Envy Me Recalls LaBri's Body Health Atomic Due to Undeclared Sibutramine

    Envy Me is recalling LaBri's Body Health Atomic capsules because the product contains undeclared Sibutramine and was marketed without an approved NDA/ANDA.

    Product
    LaBri's Body Health Atomic, 60 capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0677-2017·2017-05-03

    FDA Recalls Unapproved hCG Body Shaper Product for Contamination

    The FDA is recalling hCG Body Shaper because it was marketed without approval and contains human chorionic gonadotropin, making it an unapproved drug.

    Product
    hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0494-2017·2017-03-08

    Jeffreys Drug Store Recalls Compounded Domperidone Capsules 10 mg

    Jeffreys Drug Store is recalling compounded Domperidone capsules 10 mg because the product was marketed without an approved NDA/ANDA, meaning safety and efficacy have not been established.

    Product
    Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0505-2017·2017-03-08

    Pacific Medical Solutions Recalls Nano PNC Water Due to Bacterial Contamination

    Pacific Medical Solutions is recalling Nano PNC Water because it was marketed without FDA approval and tested positive for the bacterium variovorax paradoxus.

    Product
    Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0220-2017·2016-12-28

    FDA Recalls Black Label X Capsules for Undeclared Sildenafil

    Making It a Lifestyle is recalling 1,000 bottles of Black Label X capsules nationwide because they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0210-2017·2016-12-28

    Ultimate Body Tox PRO capsules recalled for undeclared sibutramine

    FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.

    Product
    Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0222-2017·2016-12-28

    3rd Degree Capsules Recalled for Undeclared Sibutramine

    Making It a Lifestyle is recalling 3rd Degree capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0101-2017·2016-10-26

    Tiger-X Dietary Supplement Recalled for Undeclared Sildenafil

    SOS Telecom Inc. is recalling Tiger-X dietary supplements because FDA testing found undeclared sildenafil or analogs. The product was marketed without an approved NDA or ANDA.

    Product
    Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0102-2017·2016-10-26

    FDA Recalls Ninja-X Dietary Supplement for Undeclared Sildenafil

    SOS Telecom Inc. is recalling Ninja-X dietary supplements because FDA analysis found undeclared sildenafil or its analogs. The product was marketed without an approved NDA or ANDA.

    Product
    Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0107-2017·2016-10-26

    Dream Body Weight Loss Capsules Recalled for Undeclared Sibutramine

    Dream Body Weight Loss is recalling Dream Body 450 mg capsules because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    Dream Body 450 mg 30 capsules in a plastic screw on top bottle
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0108-2017·2016-10-26

    Dream Body Advanced capsules recalled for undeclared sibutramine

    Dream Body Advanced 400 mg capsules are being recalled because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.

    Product
    Dream Body Advanced 400 mg 30 capsules in brown foil packets.
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0019-2017·2016-10-19

    La' Trim Plus Capsules Recalled for Unapproved Active Ingredients

    Bee Xtreme LLC is recalling La' Trim Plus dietary supplements because FDA analysis found unapproved drugs sibutramine and phenolphthalein.

    Product
    La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1452-2016·2016-08-10

    Let's Talk Health Recalls Unapproved Oxygen Nasal Wash Solution

    Let's Talk Health is recalling 417 bottles of Oxygen Nasal Wash because the product was marketed without FDA approval and does not comply with nasal decongestant monograph requirements.

    Product
    Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2016·2016-07-20

    FDA Recalls Crocodile Bile Pills Marketed as Unapproved Asthma Drug

    Murray International Trading Co. is recalling Crocodile Bile Pills for Asthma because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2016·2016-07-20

    FUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA

    Murray International Trading Co. is recalling FUCONPO Capsules because they are marketed as dietary supplements but bear drug claims, making them unapproved drugs.

    Product
    FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2016·2016-07-20

    Murray International Recalls Unapproved Sciatica Pills Marketed as Supplements

    Murray International Trading Co. is recalling 144 bottles of Sciatica Pills because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1357-2016·2016-07-20

    FDA Recalls Te Xiao BaiNeiTing Herbal Supplement for Unapproved Drug Claims

    Murray International Trading Co. is recalling 17 boxes of Te Xiao BaiNeiTing Herbal Supplement because the product is marketed with drug claims without an approved NDA or ANDA.

    Product
    Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1346-2016·2016-07-20

    ChingChunBao Anti-Aging Tablets Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling ChingChunBao Anti-Aging Tablets because they bear drug claims without an approved NDA or ANDA.

    Product
    ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1353-2016·2016-07-20

    Gastrodia Capsules Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Gastrodia Capsules because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1354-2016·2016-07-20

    Wupooser Kai Yeung Pill Recalled for Unapproved Drug Claims

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

    Product
    WUPOOSER 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-1351-2016·2016-07-20

    FDA Recalls Laryngitis Pills Marketed Without Approval

    Murray International Trading Co. is recalling Laryngitis Pills Herbal Supplement because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chin
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1345-2016·2016-07-20

    Murray International Recalls Unapproved Facial Pigmentation Pills

    Murray International Trading Co. is recalling 84 bottles of facial pigmentation pills marketed without FDA approval. The products bear drug claims but are labeled as dietary supplements.

    Product
    PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide