Lower riskDrug recall · FDA · Published February 17, 2021
Edge Methacholine Test Kits Recall: Incorrect Storage Temperature Risk
Edge Pharma recalls methacholine challenge test kits due to incorrect storage temperature labels. This could lead to improper storage and potential product issues. Learn what to do.
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Take action
Contact the company
📍Recalling firmEdge Pharma, LLC856 Hercules Dr · Colchester, VT 05446-8014
✎ GovInfoNow plain-language explainer
Edge Pharma is recalling methacholine challenge test kits because the storage instructions are wrong. The kits should be kept in the refrigerator (2-8°C) but are labeled for room temperature (15-25°C). This could cause the product to degrade or become unsafe if stored incorrectly. Read more at govinfonow.com/recall/36511-edge-methacholine-test-kits-recall-incorrect-storage-temperature-risk.
“Edge Methacholine Test Kits Recall: Incorrect Storage Temperature Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36511-edge-methacholine-test-kits-recall-incorrect-storage-temperature-risk. Based on FDA recall #D-0306-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0306-2021%22&limit=1).
Edge Pharma, LLC voluntarily recalled Methacholine Challenge 5-Syringe Test Kits on Feb. 17, 2021, after the FDA announced the products were labeled with incorrect room temperature storage conditions instead of required refrigerated temperatures. The recall affects 213 kits distributed nationwide.
How to tell if you have it
Brand: Edge
Product: Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe
NDC #: 05446-1600-05
Lot # 12-2020-16@10, BUD 3-30-21
Lot # 11-2020-18@11, BUD 3-02-21
The hazard
The kits were labeled with incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions, constituting a temperature abuse hazard.
Context
GovInfoNow's records show Edge Pharma, LLC has 6 other recalls on record since March 19, 2020. Other recent recalls of similar products include McKesson Gemcitabine Injection Recall (June 10, 2026), McKesson Recalls UDENYCA Injection Due to Temperature Abuse Risk (Jan. 16, 2026), and Safecor Health Fluphenazine Elixir Recall (Aug. 13, 2026).
How to tell if you have this one
Check for Edge Pharma test kits labeled 'Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe'. Look for lot numbers 12-2020-16@10 (BUD 3-30-21) or 11-2020-18@11 (BUD 3-02-21).
Brand
Edge
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Storage Conditions
Ensure the test kits are stored in the refrigerator (2-8°C) rather than at room temperature (15-25°C).
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0306-2021 (February 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0306-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.