Unrated Drug recall · FDA · Published December 15, 2025

Novadoz Glycopyrrolate Oral Solution Recall: Impurities Risk Serious Harm

Novadoz recalls specific lots of Glycopyrrolate Oral Solution (1 mg/5 mL, 16 oz) due to failed impurities tests. This medication, prescribed only, may contain harmful substances that could cause serious health issues if used.

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

🇺🇸 FDA recall #D-0300-2026Drug Novadoz ›

Recall notice

Failed Impurities/Degradation Specifications

Take action

Contact the company

Recalling firmNOVADOZ PHARMACEUTICALS LLC20 Duke Rd Ste A · Piscataway, NJ 08854-3714

✎ GovInfoNow plain-language explainer

Novadoz is recalling certain lots of Glycopyrrolate Oral Solution (1 mg/5 mL, 16 oz) because the product failed impurities and degradation tests. This means the medication could contain harmful substances that might cause serious health problems if taken as directed. Read more at govinfonow.com/recall/31615-novadoz-glycopyrrolate-oral-solution-recall-impurities-risk-serious-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/31615-novadoz-glycopyrrolate-oral-solution-recall-impurities-risk-serious-harm · Updated August 17, 2026 · FDA enforcement record: FDA #D-0300-2026

Cite this page

“Novadoz Glycopyrrolate Oral Solution Recall: Impurities Risk Serious Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31615-novadoz-glycopyrrolate-oral-solution-recall-impurities-risk-serious-harm. Based on FDA recall #D-0300-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0300-2026%22&limit=1).

Novadoz Pharmaceuticals LLC, acting voluntarily, recalled Glycopyrrolate Oral Solution distributed nationwide on Dec. 15, 2025, due to failed impurity specifications, the FDA said. The Class III recall affects specific lots of the prescription drug.

How to tell if you have it

Brand: Novadoz
Product: Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL)
Manufacturer: MSN Pharmaceuticals Inc.
Distributor: Novadoz Pharmaceuticals LLC
NDC: 72205-070-72
Lot codes: CB2505159A, CB2505160A (Exp. 04/2027); CB2505161A (Exp. 05/2027)
Distribution: US Nationwide

The hazard

The recall is due to failed impurities and degradation specifications for the Glycopyrrolate Oral Solution, according to the FDA. The agency did not report specific incidents or injuries linked to this particular recall in the official record.

Context

GovInfoNow's records show other recent recalls of similar products include Precision Dose Glycopyrrolate Oral Solution Recall (2026-07-14), Zydus Mirabegron 25mg Tablets Recall (2026-08-05), and OneSource Specialty Pharma Methohexital Sodium Recall (2026-06-07). FDA's FAERS adverse-event database contains 5,396 adverse-event reports naming this product across all years, with 4,556 marked serious and 639 listing a death.

How to tell if you have this one

Check the product label for the lot numbers CB2505159A, CB2505160A, or CB2505161A. The expiration dates for these lots are April 2027 or May 2027. This medication is only available by prescription.

Brand
Novadoz
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for lot numbers CB2505159A, CB2505160A, or CB2505161A on the bottle.
Contact Doctor
If you have the recalled lot, talk to your doctor about whether to stop using the medication.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 51 days after the firm started it.

Dec 15, 2025Firm started the recall
Jan 28, 2026FDA classified it Class III
Feb 4, 2026Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/31615-novadoz-glycopyrrolate-oral-solution-recall-impurities-risk-serious-harm">Novadoz Glycopyrrolate Oral Solution Recall: Impurities Risk Serious Harm (GovInfoNow)</a>

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-0300-2026 (December 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0300-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.