The Recall Desk
LowFDA (Drugs)·D-0339-2021·Announced 2021-05-05

Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failures

Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.

What this means for you

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

Our severity reasoning: The FDA classified this recall as Class III, which indicates a violation of labeling or manufacturing standards that is not likely to cause adverse health consequences.

Plain-English summary

Teligent Pharma, Inc. is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes. The product is identified by NDC 52565-019-51 and was distributed nationwide in the United States.

The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results for the known impurity Betamethasone 17-propionate. The affected lots include 14297 (Exp 9/2021), 15757 (Exp 6/2022), 15840 (Exp 7/2022), 15970 (Exp 9/2022), and 15993 (Exp 9/2022).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
79,416

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 (9)

  • Lot #: 14297
  • Exp 9/2021
  • 15757
  • Exp 6/2022
  • 15840
  • Exp 7/2022
  • 15970
  • Exp 9/2022
  • 15993

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 →

Related recalls

Same manufacturer · Teligent Pharma, Inc.

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Same hazard · impurity

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