The Recall Desk

Hazard

Unregistered Manufacturer recalls

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

What the numbers show

Total
19
Critical
0
Severe
8
Most recent
2016-06-29

Of the 19 unregistered manufacturer recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (42%) 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 unregistered manufacturer 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.

1–19 of 19

  • LowFDA (Drugs)·D-1047-2016·2016-06-29

    Attix Pharmaceuticals Recalls Unregistered Mycophenolate Mofetil Bulk Powder

    Attix Pharmaceuticals is recalling Mycophenolate Mofetil bulk powder due to cGMP deviations and lack of FDA registration.

    Product
    Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
    Category
    Drug
    Distribution
    1 state
  • 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-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-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
  • 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-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-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-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-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
  • 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-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-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-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-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 (Devices)·Z-1498-2014·2014-04-30

    FDA Recalls Amo-O Herbal Stimulator Gel for Unregistered Manufacturer

    Altasource LLC is recalling 70 units of Amo-O Herbal Stimulator gel because the firm is not registered as a drug manufacturer.

    Product
    Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2014·2014-04-30

    Meta Labs Recalls Nice-En-Smooth Berry Burst Lubricant for Unregistered Manufacturing

    Altasource LLC dba Meta Labs LLC is recalling Nice-En-Smooth Berry Burst lubricant because the firm is not registered as a drug manufacturer.

    Product
    Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1499-2014·2014-04-30

    Meta Labs Recalls Mega-Gen Personal Lubricant Due to Unregistered Manufacturer

    Altasource LLC is recalling Mega-Gen His and Hers Personal Lubricant because the firm is not registered as a drug manufacturer.

    Product
    Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2014·2014-04-30

    Meta Labs Recalls Hot Ice Topical Gel Due to Unregistered Manufacturer

    Altasource LLC dba Meta Labs LLC is recalling 155 units of Hot Ice topical gel because the firm is not registered as a drug manufacturer.

    Product
    Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
    Category
    Drug
    Distribution
    Distributed nationwide