The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0338-2021·Announced 2021-05-05

Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failure

Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% because it failed impurity specifications for a known degradation product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Teligent Pharma, Inc. is recalling Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15-gram tubes. The recall involves 104,784 tubes distributed nationwide in the United States. The specific lots affected are 14297 (expiring 9/2021), 15372 (expiring 3/2022), and 15841 (expiring 8/2022).

The recall was initiated because the product failed impurity and degradation specifications. Specifically, the product tested out of specification (OOS) for the known impurity Betamethasone 17-propionate. The U.S. Food and Drug Administration has classified this as a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Steroid
Hazard
Affected units
104,784

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 (6)

  • Lot #: 14297
  • Exp 9/2021
  • 15372
  • Exp 3/2022
  • 15841
  • Exp 8/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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