FDA-Drug2026-07-29Not Yet ClassifiedCHEMICAL
Precision Dose glycopyrrolate oral solution recalled for unidentified impurity
What this means
Precision Dose Inc. is recalling one lot of Glycopyrrolate Oral Solution (1 mg/5 mL) due to an unidentified impurity found during routine stability testing that does not meet specification. The affected lot (506033) expires November 30, 2026. This medication is prescription-only and supplied in unit-dose oral syringes.
- Check if you have lot 506033 of this medication (expiration 11/30/2026).
- Contact your pharmacy or prescriber if you have this lot.
- Do not use the product; return it to your pharmacy.
The agency's original wording
Hazard
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=99388Want us to check the next one for you?
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