The Recall Desk
HighFDA (Drugs)·D-0850-2022·Announced 2022-05-11

Betamethasone Dipropionate Ointment 0.05% recalled for manufacturing compliance failures

McKesson Corporation is recalling 55,440 tubes of Betamethasone Dipropionate Ointment 0.05% (Augmented) nationwide due to manufacturing compliance deviations. The recall stems from the manufacturer's discontinuation of its stability study program.

What this means for you

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 no reported illnesses or injuries. The hazard is based on the manufacturer's discontinuation of stability studies, creating a theoretical risk that the product may not maintain its safety and efficacy through the stated expiration date. Per the rubric, a recall with a theoretical hazard and no reported harm scores at most 3.

Plain-English summary

McKesson Corporation is recalling 55,440 tubes of Betamethasone Dipropionate Ointment USP 0.05% (Augmented), manufactured by Teligent Pharma, Inc. The affected lot is 15644, with expiration date 05/31/2022. The product was distributed nationwide in the United States, including Guam and the Northern Mariana Islands.

The recall is issued due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm has discontinued its stability study program, which is required to verify that the medication maintains its specified characteristics through the labeled expiration date.

Patients using this medication should consult with their healthcare provider or pharmacist regarding this recall. Healthcare facilities and dispensers should identify, quarantine, and return all affected units to the distributor.

The recalled product

Product
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 381
Manufacturer
McKesson Corporation dba McKesson Drug Company
Category
Drug — Topical Steroid
Hazard
Affected units
55,440

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: 15644
  • Exp.: 05/31/2022

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by McKesson Corporation dba McKesson Drug Company 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 5 products in this recall →

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