Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dos
Summary
The FDA issued a recall for Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision by Precision Dose Inc.. Reason: Due to an out-of-specification result for an unidentified impurity detected during routine stability testing..
Details
Source
Drug Recall
External ID
N/A
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Lot/Code Info: Lot # 506033, Exp Date: 11/30/2026.
Quantity Affected: N/A
Reason for Recall
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-14
Company
South Beloit, IL
Context & Analysis
This is a unclassified recall.
This was one of 43 drug recalls issued in the same week, part of 88 drug-related FDA actions this month.
Precision Dose Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Precision Dose Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Precision Dose Inc. have FDA actions?
Precision Dose Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "N/A" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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