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Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceu...

FDA Recall #D-0300-2026 — Class III — December 15, 2025

Recall #D-0300-2026 Date: December 15, 2025 Classification: Class III Status: Ongoing

Product Description

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

Recalling Firm

NOVADOZ PHARMACEUTICALS LLC — Piscataway, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

US Nationwide.

Code Information

Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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