Medications & Supplements/Prescription Drugs

Glycopyrrolate Oral Solution Recalled for Failed Impurity Specifications

Agency Publication Date: January 28, 2026

Summary

Novadoz Pharmaceuticals LLC is recalling three lots of Glycopyrrolate Oral Solution (1 mg/5 mL) because the product failed impurities and degradation specifications. This prescription medication is used to treat peptic ulcers and reduce excessive drooling in certain conditions. Consumers who have this medication should check their packaging for the specific lot numbers and expiration dates listed below. If you are using this product, please contact your healthcare provider or pharmacist to discuss alternative treatments while you arrange for a refund or disposal.

Risk

The product may contain impurities or degradation products that exceed safety limits, which could potentially reduce the effectiveness of the medication or cause unexpected side effects. No specific injuries or adverse events have been reported to date.

What You Should Do

Check the lot number and expiration date printed on the 16 oz. (473 mL) bottle label to see if your product is affected. Look for lot numbers CB2505159A or CB2505160A (Exp Date: 04/2027) and lot number CB2505161A (Exp Date: 05/2027).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Glycopyrrolate Oral Solution (16 oz / 473 mL)

Variants: 1 mg/5 mL, Rx only

Lot Numbers:

CB2505159A (Exp 04/2027)

CB2505160A (Exp 04/2027)

CB2505161A (Exp 05/2027)

NDC:

72205-070-72

Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854. Recall #: D-0300-2026.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98156

Status: Active

Manufacturer: NOVADOZ PHARMACEUTICALS LLC

Sold By: Pharmacies

Manufactured In: United States

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check the lot number and expiration date printed on the 16 oz. (473 mL) bottle label to see if your product is affected. Look for lot numbers CB2505159A or CB2505160A (Exp Date: 04/2027) and lot number CB2505161A (Exp Date: 05/2027).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Glycopyrrolate Oral Solution (16 oz / 473 mL)

Variants: 1 mg/5 mL, Rx only

Lot Numbers:

CB2505159A (Exp 04/2027)

CB2505160A (Exp 04/2027)

CB2505161A (Exp 05/2027)

NDC:

72205-070-72

Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854. Recall #: D-0300-2026.