The Recall Desk

Hazard

Unapproved Drug Ingredient recalls

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

What the numbers show

Total
5
Critical
3
Severe
1
Most recent
2021-08-11

Of the 5 unapproved drug ingredient recalls we have scored against our rubric, 3 (60%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

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 ingredient 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.

1–5 of 5

  • SevereFDA (Drugs)·D-0749-2021·2021-08-11

    Vy&Tea herbal tea recalled for unapproved drug ingredient sibutramine

    Qikmoov LLC is recalling Vy&Tea herbal tea because FDA analysis detected sibutramine, an ingredient not approved in an NDA or ANDA application. The product was marketed and distributed nationwide and internationally.

    Product
    Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.co
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0414-2018·2018-02-21

    FDA Recalls Bull Capsules Tainted with Sildenafil

    BYL Solutions Inc. is recalling Bull Capsules marketed without an approved NDA/ANDA and found to be tainted with sildenafil.

    Product
    Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0646-2017·2017-04-12

    FDA Recalls XtraHRD Male Enhancement Capsules for Unapproved Drug Ingredient

    Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules because they contain N-desmethyl tadalafil, an unapproved drug ingredient.

    Product
    XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0964-2016·2016-06-15

    Novacare Recalls MetaPro 360 Supplement Containing Unapproved Salicylic Acid

    Novacare, LLC is recalling MetaPro 360 Metabolic Accelerator dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.

    Product
    MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-037-2013·2012-11-07

    X-ROCK For Men Recalled for Unapproved Prescription Drug Ingredients

    XRock Industries is recalling X-ROCK For Men dietary supplements because testing revealed the presence of unapproved prescription drug ingredients.

    Product
    X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
    Category
    Drug
    Distribution
    Distributed nationwide