FDA recall, , Moderate risk
Precision Dose Glycopyrrolate Oral Solution
Glycopyrrolate Oral Solution failed impurities and degradation specifications due to an unidentified impurity.
Summary by Recall Canary from the FDA notice
What happened
Precision Dose Inc. of South Beloit, Illinois, recalled Glycopyrrolate Oral Solution, 1 mg/5 mL, a prescription product delivered in 5 mL unit-dose oral syringes, due to an out-of-specification result for an unidentified impurity detected during routine stability testing, which caused the product to fail impurities and degradation specifications. The recall began July 14, 2026, and was added to the FDA's Enforcement Report on July 23, 2026, with distribution nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Glycopyrrolate Oral Solution
- Strength
- 1 mg
- Lot code
- 506033
From the FDA notice
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).
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Precision Dose Inc.South Beloit, Illinois
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99388
- Recall number
- D-0741-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
