FDA DrugsClass III
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured ...
Published: February 4, 2026Recall ID: D-0300-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Piscataway |
| State | NJ |
| Openfda › Unii | V92SO9WP2I |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 999961 |
| Openfda › Spl id | 98820c01-1853-45d8-9da5-875fcdf5f9ab |
| Openfda › Brand name | GLYCOPYRROLATE |
| Openfda › Spl set id | 98820c01-1853-45d8-9da5-875fcdf5f9ab |
| Openfda › Package ndc | 72205-070-72 |
| Openfda › Product ndc | 72205-070 |
| Openfda › Generic name | GLYCOPYRROLATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | GLYCOPYRROLATE |
| Openfda › Manufacturer name | Novadoz Pharmaceuticals LLC |
| Openfda › Application number | ANDA216084 |
| Openfda › Is original packager | true |
| Event id | 98156 |
| Address 1 | 20 Duke Rd Ste A |
| Address 2 | N/A |
| Code info | Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027 |
| Postal code | 08854-3714 |
| Report date | 20260204 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260128 |
Overview
- Recalling FirmNOVADOZ PHARMACEUTICALS LLC
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide.