The Recall Desk

Manufacturer

Downing Labs, LLC

48 recalls in our database name Downing Labs, LLC as the manufacturing or recalling firm.

What the numbers show

Total
48
Critical
0
Severe
46
Most recent
2015-11-25

Of the 48 recalls from Downing Labs, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 46 (96%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 48

  • SevereFDA (Drugs)·D-0376-2016·2015-11-25

    Downing Labs Recalls M.I.C Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling M.I.C Injection (Preserved) because the company cannot ensure the product is sterile. The recall affects 172 vials distributed in the US and internationally.

    Product
    M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0342-2016·2015-11-25

    Downing Labs Recalls Ascorbic Acid Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.

    Product
    Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2016·2015-11-25

    Downing Labs Recalls L-Glutathione Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 467 vials of L-Glutathione Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2016·2015-11-25

    Downing Labs Recalls HCG Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling 1,062 vials of HCG (Lyophilized) Injectable because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2016·2015-11-25

    Downing Labs Recalls Chromium Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.

    Product
    Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0368-2016·2015-11-25

    Downing Labs Recalls L-Arginine Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.

    Product
    L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0340-2016·2015-11-25

    Downing Labs Recalls EDTA Disodium Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling EDTA Disodium Injectable vials because the company cannot ensure the product is sterile.

    Product
    EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0371-2016·2015-11-25

    Downing Labs Recalls Folic Acid Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 178 vials of Folic Acid Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed in the US and 17 other countries.

    Product
    Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0379-2016·2015-11-25

    Downing Labs Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 34 vials of Testosterone Cypionate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2016·2015-11-25

    Downing Labs Recalls B12 Injection Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling 98 vials of B12 Injection 12.5/12.5MG due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0339-2016·2015-11-25

    Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.

    Product
    L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0350-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2016·2015-11-25

    Downing Labs Recalls EDTA Calcium Disodium Injectable Due to Sterility Concerns

    Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.

    Product
    EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2016·2015-11-25

    Downing Labs Recalls L-Tyrosine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 29 vials of L-Tyrosine Injectable because the product lacks assurance of sterility. The affected product was distributed nationwide and in multiple international markets.

    Product
    L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2016·2015-11-25

    Downing Labs Recalls DMSO 99% Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.

    Product
    DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2016·2015-11-25

    Downing Labs Recalls DMPS Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.

    Product
    DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0362-2016·2015-11-25

    Downing Labs Recalls TNPDR Injection Buffered Due to Sterility Concerns

    Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.

    Product
    TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0360-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 160 vials of Magnesium Sulfate Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0381-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 304 vials of Magnesium Sulfate Injection because the product lacks assurance of sterility. The affected vials were distributed nationwide and internationally.

    Product
    Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0367-2016·2015-11-25

    Downing Labs Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 289 vials of Magnesium Chloride Hexahydrate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0347-2016·2015-11-25

    Downing Labs Recalls Vitamin D3 Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Vitamin D3 Injectable, 10,000 U/mL, 10mL vials due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0363-2016·2015-11-25

    Downing Labs Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.

    Product
    Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2016·2015-11-25

    Downing Labs Recalls Dexpanthenol Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 235 vials of Dexpanthenol Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2016·2015-11-25

    Downing Labs Recalls Cyanocobalamin Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.

    Product
    Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0358-2016·2015-11-25

    Downing Labs Recalls TNPRDC Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 171 vials of TNPRDC Injection because the company cannot assure the sterility of the product. The recall covers all lots distributed nationwide and internationally.

    Product
    TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide