The Recall Desk
ModerateFDA (Drugs)·D-0698-2022·Announced 2022-03-30

Triamcinolone Acetonide Lotion Recalled for cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Triamcinolone Acetonide Lotion USP 0.025% due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.

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 or injuries. The hazard is a manufacturing practice deviation (discontinuation of stability studies), which is a precautionary compliance issue rather than an immediate documented health threat.

Plain-English summary

Teligent Pharma, Inc., of Buena, New Jersey, is recalling Triamcinolone Acetonide Lotion USP, 0.025%, supplied in 60 mL (60 grams) bottles, NDC 52565-010-59. The recall affects approximately 112,769 bottles distributed nationwide in the USA and Puerto Rico.

The recall is issued because the firm is discontinuing its stability study program, which constitutes a deviation from current Good Manufacturing Practice (cGMP) standards. All products within their expiration dates are included in this recall.

Affected batches include: 14796 (Exp. 12/31/2022), 14797 (Exp. 1/31/2023), 14534, 15571, 15572 (Exp. 4/30/2023), 15746, 15756 (Exp. 6/30/2023), 15982 (Exp. 9/30/2023), 16043, 16144, 16149 (Exp. 10/31/2023), 16433, 16434 (Exp. 2/29/2024), 16656, 16679 (Exp. 3/31/2024), and 16784 (Exp. 5/31/2024).

Patients and healthcare providers should discontinue use of affected batches and consult with their healthcare provider regarding alternative treatment options. The product is prescription-only (Rx only).

The recalled product

Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Steroid
Hazard
Affected units
112,769

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 (20)

  • Batch: 14796
  • Exp. 12/31/2022
  • 14797
  • Exp. 1/31/2023
  • 14534
  • 15571
  • 15572
  • Exp. 4/30/2023
  • 15746
  • 15756
  • Exp. 6/30/2023
  • 15982
  • Exp. 9/30/2023
  • 16043
  • 16144
  • 16149
  • Exp. 10/31/2023
  • 16433
  • 16434
  • Exp. 2/29/2024

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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