CLASS III ONGOING Drug recall · Reported 4 Feb 2026 · FDA Enforcement Report
Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz Pharmaceuticals
Novadoz Pharmaceuticals is recalling Glycopyrrolate Oral Solution, 1 mg, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0300-2026
- FDA event ID
- 98156
- Recalling firm
- Novadoz Pharmaceuticals, Piscataway, NJ
- Brand
- Glycopyrrolate
- Manufacturer
- Novadoz Pharmaceuticals LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 15 Dec 2025
- FDA classified
- 28 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Dec 2025 | Recall initiated by company | |
| 28 Jan 2026 | Classified by FDA | +44 days |
| 4 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72
Where it was distributed
US Nationwide.
Questions about this recall
Is Glycopyrrolate Oral Solution, 1 mg recalled?
Yes. Novadoz Pharmaceuticals recalled Glycopyrrolate Oral Solution, 1 mg on 15 Dec 2025. The recall is Class III and its status is Ongoing. Recall number D-0300-2026.
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Glycopyrrolate recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per 2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 2mg/ML Vial recalled by HF Acquisition CoGlycopyrrolate | HF Acquisition Co | Packaging Defects | AZ, CA, TX |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 2 mg/mL Single Dose Vial x 25 vials recalledGlycopyrrolate | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |