The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0679-2022·Announced 2022-03-30

Diclofenac Sodium Topical Solution recalled by Teligent Pharma

Teligent Pharma is recalling all unexpired batches of Diclofenac Sodium Topical Solution 1.5% due to current good manufacturing practice (cGMP) deviations related to discontinuation of the firm's stability study program.

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: This is an FDA Class II recall involving a manufacturing practice deviation (discontinuation of stability studies) rather than a direct safety hazard with reported injuries or illnesses. The source text states no adverse events, making this a precautionary/compliance-based recall typical of Class II classifications.

Plain-English summary

Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles (NDC 52565-002-05) distributed nationwide in the USA and Puerto Rico. The recall affects approximately 16,643 bottles.

The recall is being issued because the manufacturer is discontinuing its stability study program, which represents a deviation from current good manufacturing practice (cGMP) requirements. All products within their expiration dates are affected by this recall.

Affected batches include: Batch 15066 and 15389 (expiration 3/31/2023); Batch 15437 (expiration 12/31/2023); Batch 16823 (expiration 4/30/2024); and Batches 16825 and 16826 (expiration 4/30/2024).

Patients and healthcare providers who have this product should contact Teligent Pharma, Inc. or consult their healthcare provider regarding alternative treatment options.

The recalled product

Product
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Solution
Hazard
Affected units
16,643

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)

  • Batch: 15066
  • 15389 Exp. 3/31/2023
  • 15437
  • Exp. 12/31/2023
  • 16823
  • Exp. 4/30/2024
  • 16825
  • 16826

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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