Teligent Pharma Betamethasone Dipropionate Ointment Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

Lot numbers, UPCs & expiration codes

Lot 11852, exp date 08/2020

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1391-2019
Classification: Class III
Status: Terminated
Recall initiated: May 20, 2019
FDA report date: Jun 26, 2019
Quantity: 9360 tubes
Recall type: Voluntary: Firm initiated
Recalling firm: Teligent Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-1391-2019, exactly as published.

Show all FDA fields

City: Buena
State: NJ
Status: Terminated
Country: United States
Event ID: 82983
Address: 105 Lincoln Avenue
Code information: Lot 11852, exp date 08/2020
Postal code: 08310
Report date: Jun 26, 2019
Product type: Drugs
Recall number: D-1391-2019
Classification: Class III
Recalling firm: Teligent Pharma, Inc.
Product quantity: 9360 tubes
Termination date: Jan 27, 2025
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
Distribution pattern: Nationwide
Recall initiation date: May 20, 2019
Initial firm notification: Letter
Center classification date: Jun 14, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1391-2019, published Jun 26, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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