The Recall Desk
ModerateFDA (Drugs)·D-0429-2022·Announced 2022-02-02

Drug Recall: Cantharidin Gel-Forming Suspension CGMP Deviations

Edge Pharma, LLC is recalling Cantharidin Gel-Forming Suspension 0.7% nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall involves 1173 vials distributed to healthcare facilities.

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 any reported illnesses or injuries. The source text states no actual harm, only manufacturing process violations. Class II recalls with no hospitalization or injury reports typically fall into the Moderate category per the severity rubric.

Plain-English summary

Edge Pharma, LLC is voluntarily recalling Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, multiple-dose vials for topical use (NDC 05446-0572-03) due to deviations from Current Good Manufacturing Practice (CGMP).

The affected product was manufactured by Edge Pharma, LLC, located at 856 Hercules Dr., Colchester, VT 05546. A total of 1173 vials have been distributed nationwide. The recalled lot codes are: 06-2021-11@6 (12-08-2021), 07-2021-08@13 (01-04-2022), 08-2021-06@6 (02-02-2022), 08-2021-20@10 (02-16-2022), 08-2021-26@6 (02-22-2022), 08-2021-27@7 (02-23-2022), 09-2021-02@5 (03-01-2022), 09-2021-17@8 (03-16-2022), and 09-2021-29@12 (03-28-2022).

The firm initiated this recall in December 2021, and it was terminated on June 7, 2023. Patients or healthcare providers who have this product in their possession should discontinue use and consult with their healthcare provider regarding treatment alternatives. The FDA classified this as a Class II recall on January 24, 2022.

The recalled product

Product
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
Manufacturer
Edge Pharma, LLC
Category
Drug — Topical / CGMP Deviation
Hazard
Affected units
1,173

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 06-2021-11@6 12-08-2021
  • 07-2021-08@13 01-04-2022
  • 08-2021-06@6 02-02-2022
  • 08-2021-20@10 02-16-2022
  • 08-2021-26@6 02-22-2022
  • 08-2021-27@7 02-23-2022
  • 09-2021-02@5 03-01-2022
  • 09-2021-17@8 03-16-2022 & 09-2021-29@12 03-28-2022

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 →

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