Teligent Pharma Betamethasone Dipropionate Ointment Recall

Why it was recalled

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Product description

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

Lot numbers, UPCs & expiration codes

Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022

Where it was sold

USA 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-0338-2021
Classification: Class III
Status: Terminated
Recall initiated: Feb 2, 2021
FDA report date: May 5, 2021
Quantity: 104,784 tubes
Recall type: Voluntary: Firm initiated
Recalling firm: Teligent Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0338-2021, exactly as published.

Show all FDA fields

City: Buena
State: NJ
Status: Terminated
Country: United States
Event ID: 87266
Address: 105 Lincoln Avenue
Code information: Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022
Postal code: 08310
Report date: May 5, 2021
Product type: Drugs
Recall number: D-0338-2021
Classification: Class III
Recalling firm: Teligent Pharma, Inc.
Product quantity: 104,784 tubes
Termination date: Aug 15, 2024
Reason for recall: Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Distribution pattern: USA Nationwide
Recall initiation date: Feb 2, 2021
Initial firm notification: Letter
Center classification date: Apr 23, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0338-2021, published May 5, 2021. 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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