Glycopyrrolate Oral Solution recall
FDA recall D-0741-2026 · initiated Jul 14, 2026
Precision Dose Inc. recalled Glycopyrrolate Oral Solution in Jul 2026 — an FDA Class II recall (D-0741-2026) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- 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).
- Recalling company
- Precision Dose Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jul 14, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Glycopyrrolate Oral Solution recalled?
- Precision Dose Inc. recalled Glycopyrrolate Oral Solution in Jul 2026 — an FDA Class II recall (D-0741-2026) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Glycopyrrolate Oral Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0741-2026 was: Failed Impurities/Degradation Specifications
- Is a recalled Glycopyrrolate Oral Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Glycopyrrolate Oral Solution are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 506033, Exp Date: 11/30/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0741-2026.