The Recall Desk
ModerateFDA (Drugs)·D-0438-2022·Announced 2022-02-02

Lidocaine HCl / Oxymetazoline HCl Nasal Solution Recalled for CGMP Deviations

Edge Pharma, LLC is recalling Lidocaine HCl / Oxymetazoline HCl Nasal Solution (4% / 0.05%, 240mL) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for CGMP deviations without reported illnesses or injuries. The source text does not mention any adverse health events, hospitalization, or safety incidents—only manufacturing practice violations. Under the rubric, Class II recalls without reported harm are typically Moderate.

Plain-English summary

Edge Pharma, LLC is recalling Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, packaged in multiple-dose containers for intranasal use. The product is identified by NDC 05446-1256-01. Approximately 386 bottles have been distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the firm. The FDA classified this recall as Class II.

Consumers who have this product should not use it. Patients and healthcare providers with questions should contact Edge Pharma, LLC at 856 Hercules Dr., Colchester, VT 05446, or refer to the FDA's drug recalls page for more information.

The recalled product

Product
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label
Manufacturer
Edge Pharma, LLC
Category
Drug — Nasal Solution / Topical
Hazard
  • manufacturing-deviations
  • cgmp-non-compliance

Distribution

Distributed nationwide across the United States.

Related recalls

Same category