Glycopyrrolate Oral Solution — Class III drug recall D-0300-2026
Ongoing recall by NOVADOZ PHARMACEUTICALS LLC, reported 2026-02-04, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0300-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOVADOZ PHARMACEUTICALS LLC, Piscataway, NJ, United States |
| Recall initiated | 2025-12-15 |
| Classified | 2026-01-28 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 72205-0070, 72205-0070-72 |
| Lot numbers | CB2505159A, CB2505160A, CB2505161A |
| Expiration dates | 2027-04, 2027-05 |
Product
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
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0300-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.