Class II · Moderate risk
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
Glycopyrrolate Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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).
Affected NDCs
68094-0073-01
68094-0073-58
Compare with the code on your package — it is the most precise check available.
Drug: Glycopyrrolate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Glycopyrrolate NDC 68094-0073 |
1 mg/5mL | Solution Oral |
Precision Dose, Inc. | Rx |
- Recalling firm
- Precision Dose Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0741-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Glycopyrrolate recalls
See all
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
glycopyrrolate 1 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class III · Low risk
Glycopyrrolate Injection
Labeling: Label Mix-up
Other recalls by Precision Dose Inc.
All 2026 recalls
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Chlorhexidine Gluconate Oral Rinse USP 0.12%
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class II · Moderate risk
Ranitidine Oral Solution
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
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