The Recall Desk
ModerateFDA (Drugs)·D-0297-2022·Announced 2022-01-05

Betamethasone Dipropionate Lotion recalled for failed stability test

Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP 0.05% (Augmented) due to failure to meet specification for the Active Pharmaceutical Ingredient particle test during routine stability testing.

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. The source text does not report any illnesses, injuries, or deaths. The hazard is a failed specification test—a quality/stability issue without documented patient harm, which fits the Moderate category for precautionary pharmaceutical recalls.

Plain-English summary

Teligent Pharma, Inc. is recalling Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottles. This is a prescription corticosteroid lotion distributed nationwide in the USA.

The recall was initiated because lot 16569 failed to meet specification for the Active Pharmaceutical Ingredient (API) particle test during routine stability testing.

Consumers who have received this product should consult their healthcare provider or pharmacist for guidance. The affected lot number is 16569 with an expiration date of 9/2022.

The recalled product

Product
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
3,792

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)

  • Lot # 16569
  • Exp 9/2022

Distribution

Distributed nationwide across the United States.

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Same manufacturer · Teligent Pharma, Inc.

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Same hazard · stability test failure

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