Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0443-2022·Announced 2022-02-02

Phenol Topical Solution recalled for CGMP manufacturing deviations

Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The FDA classified this as Class II. The source text does not report any illnesses, injuries, or adverse events. The recall is based on theoretical manufacturing compliance deviations without evidence of actual harm. This meets the criteria for Moderate severity.

Plain-English summary

Edge Pharma, LLC is voluntarily recalling Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial (NDC 05446-1211-03) manufactured at 856 Hercules Drive, Colchester, Vermont. The recall involves 1,861 jars distributed nationwide and was initiated on December 6, 2021.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The FDA classified this as a Class II recall on January 24, 2022, and the recall was publicly announced via press release on February 2, 2022.

Affected lot codes and date ranges are: 07-2021-12@9 (07/22/21–08/11/21); 08-2021-11@10 (08/25/21–09/10/21); 08-2021-12@12 (09/07/21–10/06/21); 09-2021-22@5 (10/12/21–10/28/21); 10-2021-07@8 (10/25/21–10/28/21); 10-2021-08@4 (10/28/21–11/12/21); and 11-2021-01@7 (11/15/21–12/01/21). Consumers or healthcare providers with this product should contact Edge Pharma, LLC for instructions on return or disposal. The recall was terminated on June 7, 2023.

The recalled product

Product: Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Manufacturer: Edge Pharma, LLC
Category: Drug — Topical Solution
Hazard: cgmp-deviation
manufacturing-quality
Affected units: 1,861

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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