The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0669-2022·Announced 2022-03-30

FDA Recalls Betamethasone Dipropionate Lotion Due to Manufacturing Deviations

Teligent Pharma is recalling Betamethasone Dipropionate Lotion due to manufacturing practice deviations and discontinuation of the stability study program. The recall affects 43,218 bottles distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with manufacturing and stability deviations. No illnesses or injuries have been reported, and the hazard is theoretical (lack of assurance about stability) rather than a detected defect, placing this at the High severity level per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Teligent Pharma, Inc. is recalling Betamethasone Dipropionate Lotion USP, 0.05% (Augmented) due to current Good Manufacturing Practice (cGMP) deviations. The affected product includes 30 mL bottles (NDC 52565-023-29) and 60 mL bottles (NDC 52565-023-59).

The company has discontinued its stability study program, which means it can no longer guarantee that the medication will maintain its intended potency and safety throughout its shelf life. As a precautionary measure, all units within their expiration dates are being recalled.

Approximately 43,218 bottles are affected, distributed nationwide in the USA and Puerto Rico. Multiple batches are included in this recall, with original expiration dates ranging from March 2022 through September 2022.

Consumers and healthcare providers with this product should discontinue use and contact a healthcare provider for alternative treatment options.

The recalled product

Product
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
Manufacturer
Teligent Pharma, Inc.
Category
Drug
Hazard
Affected units
43,218

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 (10)

  • Batch: a) 15998
  • Exp. 3/31/2022
  • b) 16104
  • Exp. 4/30/2022
  • 16133
  • Exp. 5/31/2022
  • 16391
  • Exp. 8/31/2022
  • 15440
  • Exp. 9/30/2022

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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