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Downing Labs, LLC

Complete recall history across all FDA and CPSC categories — 48 total recalls

Downing Labs, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (48)

FDA drug safety enforcement actions by Downing Labs, LLC

Date Product Reason Class
Oct 16, 2015 Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II
Oct 16, 2015 Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II
Oct 16, 2015 Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II
Oct 16, 2015 M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II
Oct 16, 2015 Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II
Oct 16, 2015 Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, ... Lack of Assurance of Sterility Class II
Oct 16, 2015 Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II
Oct 16, 2015 Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Lab... Lack of Assurance of Sterility Class II
Oct 16, 2015 L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II
Oct 16, 2015 Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downin... Lack of Assurance of Sterility Class II
Oct 16, 2015 Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30m... Lack of Assurance of Sterility Class II
Oct 16, 2015 L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II
Oct 16, 2015 Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEw... Lack of Assurance of Sterility Class II
Oct 16, 2015 EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II
Oct 16, 2015 Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II
Oct 16, 2015 Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Lab... Lack of Assurance of Sterility Class II
Oct 16, 2015 EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II
Oct 16, 2015 Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II
Oct 16, 2015 Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II
Oct 16, 2015 TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen R... Lack of Assurance of Sterility Class II
Oct 16, 2015 Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downi... Lack of Assurance of Sterility Class II
Oct 16, 2015 Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II
Oct 16, 2015 DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II
Oct 16, 2015 Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II
Oct 16, 2015 MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II
Oct 16, 2015 Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II
Oct 16, 2015 DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Sui... Lack of Assurance of Sterility Class II
Oct 16, 2015 Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Ph... Lack of Assurance of Sterility Class II
Oct 16, 2015 Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II
Oct 16, 2015 L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II
Oct 16, 2015 HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II
Oct 16, 2015 L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II
Oct 16, 2015 Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II
Oct 16, 2015 Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwe... Lack of Assurance of Sterility Class II
Oct 16, 2015 Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II
Oct 16, 2015 DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd... Lack of Assurance of Sterility Class II
Oct 16, 2015 TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite... Lack of Assurance of Sterility Class II
Oct 16, 2015 Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II
Oct 16, 2015 MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, D... Lack of Assurance of Sterility Class II
Oct 16, 2015 Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McE... Lack of Assurance of Sterility Class II
Oct 16, 2015 Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, ... Lack of Assurance of Sterility Class II
Oct 16, 2015 B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Su... Lack of Assurance of Sterility Class II
Oct 16, 2015 Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II
Oct 16, 2015 Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II
Oct 16, 2015 Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4... Lack of Assurance of Sterility Class II
Oct 16, 2015 Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II
Oct 16, 2015 Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500... Lack of Assurance of Sterility Class II
Oct 16, 2015 L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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