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Stop using now Drug recall · FDA · Published October 16, 2015

Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Risk

Downing Labs recalls all lots of L-Tryptophan Injectable (30mg/mL) due to lack of sterility assurance. Check if you have this Rx drug.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0339-2016DrugDowning Labs ›
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Contact the company

Recalling firmDowning Labs, LLC4001 McEwen Rd Suite 110 · Dallas, TX 75244-5020
✎ GovInfoNow plain-language explainer

What happened, in plain English

Downing Labs, LLC is recalling all lots of its L-Tryptophan Injectable, a prescription-only medication supplied in 30mL vials. The recall is necessary because the manufacturer could not assure that the product was sterile. This issue affects a small quantity of 16 vials distributed both within the United States and internationally. Read more at govinfonow.com/recall/43520-downing-labs-llc-recalls-l-tryptophan-injectable-30mg-ml-30ml.

Source Summary by GovInfoNow · govinfonow.com/recall/43520-downing-labs-llc-recalls-l-tryptophan-injectable-30mg-ml-30ml · Updated October 11, 2026 · FDA enforcement record: FDA #D-0339-2016

Cite this page

“Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43520-downing-labs-llc-recalls-l-tryptophan-injectable-30mg-ml-30ml. Based on FDA recall #D-0339-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0339-2016%22&limit=1).

Why it’s dangerous

The primary hazard is a lack of assurance of sterility, meaning the vials may contain harmful microorganisms. Using non-sterile injectable medication can lead to serious infections or other complications at the injection site or systemically.

Who’s affected

This recall affects patients or veterinary professionals who have been prescribed or supplied with L-Tryptophan Injectable from Downing Labs. Because the product is a prescription drug (Rx only), it is likely used in clinical settings rather than by general consumers.

How to tell if you have this one

Look for L-Tryptophan Injectable with a concentration of 30mg/mL in 30mL vials, manufactured by Downing Labs, LLC. The recall covers all lots of this product. It was distributed nationwide in the US and to several countries including Australia, Brazil, Japan, and others.

  • Brand
    Downing Labs
  • Category
    Drug
FDA recall event · 48 products

All 48 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Recall numberProduct, codes & lotsQuantity
D-0337-2016L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots14 vials
D-0338-2016L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots29 vials
D-0339-2016L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots16 vials
D-0340-2016EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots2279 vials
D-0341-2016Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots108 vials
D-0342-2016Ascorbic 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; All lots4857 vials
D-0343-2016MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots502 vials
D-0344-2016Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots25 vials
D-0345-2016Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots881 vials
D-0346-2016Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots12 vials
D-0347-2016Vitamin 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; All lots27 vials
D-0348-2016Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots363 vials
D-0349-2016Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots123 vials
D-0350-2016Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots320 vials
D-0351-2016Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots20 vials
D-0352-2016Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots20 vials
D-0353-2016Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots2189 vials
D-0354-2016Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots186 vials
D-0355-2016HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots1062 vials
D-0356-2016Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots30 vials
D-0357-2016EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots104 vials
D-0358-2016TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots171 vials
D-0359-2016DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots475 vials
D-0360-2016Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots160 vials
D-0361-2016Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots23 vials
D-0362-2016TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots481 vials
D-0363-2016Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots286 vials
D-0364-2016Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots287 vials
D-0365-2016Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots106 vials
D-0366-2016B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots98 vials
D-0367-2016Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots289 vials
D-0368-2016L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots32 vials
D-0369-2016DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots187 vials
D-0370-2016L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots467 vials
D-0371-2016Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots178 vials
D-0372-2016Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots28 vials
D-0373-2016Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots280 vials
D-0374-2016DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots16 vials
D-0375-2016Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots235 vials
D-0376-2016M.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; All lots172 vials
D-0377-2016Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots74 vials
D-0378-2016Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots72 vials
D-0379-2016Testosterone 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; All lots34 vials
D-0380-2016Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots225 vials
D-0381-2016Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots304 vials
D-0382-2016Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots7 vials
D-0383-2016MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots49 vials
D-0384-2016Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435; All lots315 vials
Based on the official FDA remedy

What to do — step by step

  1. Stop Using the Product

    Do not use any vials of L-Tryptophan Injectable from Downing Labs due to the sterility risk.

  2. Contact Manufacturer

    Call Downing Labs at 1-800-914-7435 for further instructions on how to handle the recalled vials.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Oct 16, 201512. FDA classified it Class II: Nov 18, 201523. Published in FDA’s Enforcement Report: Nov 25, 201534. FDA terminated the recall: Sep 22, 2016420152016
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold or distributed?

The product was distributed nationwide in the US and internationally to countries including Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Philippines, Singapore, Thailand, Trinidad and Tobago, and Taiwan.

How many units are affected by this recall?

The recall involves a total of 16 vials.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0339-2016 (October 16, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0339-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA