Novadoz Pharmaceuticals LLC Recalls Glycopyrrolate Oral Solution Due to Impurity Specifications
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Novadoz Pharmaceuticals LLC has issued a voluntary recall for specific lots of Glycopyrrolate Oral Solution after the product failed to meet impurity and degradation standards.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, pharmaceuticals.
What Happened
Novadoz Pharmaceuticals LLC has initiated a voluntary recall of several lots of Glycopyrrolate Oral Solution. The recall was triggered after testing revealed that the affected lots failed to meet established specifications for impurities and degradation. This Class III recall was officially classified by the FDA on January 28, 2026.
Which Products Are Affected
The recall involves Glycopyrrolate Oral Solution, 1 mg/5 mL, packaged in 16 oz. (473 mL) bottles. The product is a prescription drug (Rx only) manufactured by MSN Pharmaceuticals Inc. and distributed by Novadoz Pharmaceuticals LLC.
Product Details:
- NDC Number: 72205-070-72
- Lot Numbers & Expiration:
- Lot # CB2505159A (Exp: 04/2027)
- Lot # CB2505160A (Exp: 04/2027)
- Lot # CB2505161A (Exp: 05/2027)
- Distribution: The product was distributed nationwide throughout the United States.
What You Should Do
Consumers, pharmacists, and healthcare providers are advised to check their current inventory for the affected lot numbers listed above. The recalling firm, Novadoz Pharmaceuticals LLC, initiated the process via notification letters. For further information regarding returns or specific medical concerns, patients should contact their healthcare provider or the distributing firm located at 20 Duke Rd Ste A, Piscataway, NJ 08854.
Why This Matters
This recall is necessary to ensure that prescription medications maintain their chemical integrity and purity. Using medications that have exceeded impurity or degradation limits may impact the efficacy or safety of the treatment.
Source
Information provided by the U.S. Food and Drug Administration (FDA) under recall number D-0300-2026.
Original source: FDA Official Notice ↗
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