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.

426–450 of 547

  • SevereFDA (Drugs)·D-1549-2014·2014-08-27

    Doctor's Best Red Yeast Rice Recalled for Undeclared Lovastatin

    Doctor's Best is recalling Red Yeast Rice 1200 capsules because FDA analysis found undeclared lovastatin, making it an unapproved new drug.

    Product
    Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1534-2014·2014-08-20

    Lite Fit USA Recalled for Undeclared Sibutramine

    Bacai, Inc. is voluntarily recalling Lite Fit USA supplements containing undeclared sibutramine, making them unapproved new drugs.

    Product
    Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1521-2014·2014-08-13

    BCAA 4% Injection Recalled for Lack of FDA Approval

    Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

    Product
    BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1531-2014·2014-08-13

    FDA Recalls G.A.C. 375 Injection Due to Unregistered Manufacturer

    The FDA is recalling G.A.C. 375 Injection USP because the manufacturing firm is not registered with the FDA as a drug manufacturer.

    Product
    G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials

    Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide

    Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1528-2014·2014-08-13

    B Complex Injection Recalled for Lack of FDA Approval

    Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

    Product
    B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1530-2014·2014-08-13

    FDA Recalls Unapproved Lipo 8 Injection Vials Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Lipo 8 Injection USP 200 mg/ml vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1532-2014·2014-08-13

    L-Carnitine Injection Recalled for Lack of FDA Approval and Registration

    Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml because it was marketed without an approved NDA/ANDA and the manufacturer is not registered with the FDA.

    Product
    L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1526-2014·2014-08-13

    Unapproved Injectable B Complex Recall Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Super MIC B Complex injections because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP because the manufacturer is not registered with the FDA.

    Product
    Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1527-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide and Abroad

    Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin injections because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.

    Product
    Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1520-1014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin Injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA or ANDA.

    Product
    Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1519-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1522-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide

    Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1533-2014·2014-08-13

    FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad

    Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.

    Product
    Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1525-2014·2014-08-13

    Medical Supply Liquidators Recalls Unapproved MIC Injection Vials

    Medical Supply Liquidators LLC is recalling MIC Injection USP vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1495-2014·2014-08-06

    Dermamedics Recalls Unapproved Therametics Complexion Repair Topical Emulsion

    Dermamedics, L.L.C. is recalling Therametics Complexion Repair Topical Rehydrating Emulsion because the FDA determined the products are unapproved new drugs and misbranded.

    Product
    Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1489-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Baby's Relief Creams

    Dermamedics, L.L.C. is recalling specific lots of Dermamedics and Therametics Baby's Relief Calm and Repair Cream because the products are unapproved new drugs and misbranded.

    Product
    Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1491-2014·2014-08-06

    Dermamedics Serum Recalled for Lacking FDA Approval

    Dermamedics, L.L.C. is recalling Calm and Correct Serum because the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1487-2014·2014-08-06

    Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1490-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

    Dermamedics, L.L.C. is recalling Dermamedics and Therametics Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1494-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

    Dermamedics, L.L.C. is recalling specific Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was dist
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1492-2014·2014-08-06

    Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1488-2014·2014-08-06

    Dermamedics Calm & Correct Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Calm & Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
    Category
    Drug
    Distribution
    Distributed nationwide