Glycopyrrolate Recall: Novadoz Pharmaceuticals Oral Solution
Announced 2026-02-04 · FDA
FDA is recalling Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz (473 mL), Rx only. The recall is due to failed impurities/degradation specifications and products distributed nationwide in the United States. Involved lots are CB2505159A, CB2505160A (Exp 04/2027) and CB2505161A (Exp 05/2027); manufactured by MSN Pharmaceuticals Inc. and distributed by Novadoz Pharmaceuticals LLC; NDC 72205-070-72.
| Brand | NOVADOZ PHARMACEUTICALS LLC |
|---|---|
| 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 | Failed Impurities/Degradation Specifications |
| Severity | low |
| Units affected | N/A |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027 |
WHAT YOU SHOULD DO
- Check your Glycopyrrolate Oral Solution bottles for lot CB2505159A, CB2505160A, or CB2505161A and discard any that are affected.
- Do not use affected product.
- Return the product to the place of purchase or contact your pharmacy for instructions and a replacement if available.
- If you have concerns or symptoms, consult your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.