The Recall Desk
ModerateFDA (Drugs)·D-0685-2022·Announced 2022-03-30

Fluocinonide Topical Solution Recalled Due to Manufacturing Deviations

Teligent Pharma recalled Fluocinonide Topical Solution USP 0.05% nationwide because the manufacturer is discontinuing stability testing. Without ongoing verification, the company cannot ensure product safety.

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 with no reported illnesses, injuries, or deaths. The recall is precautionary, initiated due to manufacturing compliance deviations and discontinuation of stability testing rather than reported product harm.

Plain-English summary

Teligent Pharma, Inc. is recalling Fluocinonide Topical Solution USP, 0.05%, a prescription topical corticosteroid. The recall includes approximately 7,169 bottles in two package sizes: 20 mL bottles (NDC 52565-025-20) and 60 mL bottles (NDC 52565-025-59). The affected batch is 17138, with an expiration date of February 28, 2023.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations. The manufacturer is discontinuing its stability study program, which is required to verify that medications maintain their quality and safety throughout their shelf life.

The recalled product was distributed nationwide in the United States and Puerto Rico.

Consumers or healthcare providers who have this medication should stop using it and consult a healthcare professional about appropriate alternatives. The product should be returned to the pharmacy or disposed of according to local guidelines.

The recalled product

Product
Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
7,169

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 (2)

  • Batch: 17138
  • Exp. 2/28/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Teligent Pharma, Inc. 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 37 products in this recall →

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