Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals Clobetasol Lotion Recalled for Stability Deviations

Agency Publication Date: April 14, 2022

Summary

Preferred Pharmaceuticals, Inc. is recalling 1,568 bottles of Clobetasol Propionate Lotion 0.05% (Generic for Temovate). The recall was issued because the original manufacturer, Teligent Pharma, Inc., stopped its stability study program, meaning the medication's effectiveness and quality cannot be guaranteed through its expiration date. No incidents or injuries have been reported to date regarding this issue.

Risk

Because the manufacturer stopped monitoring the product's stability, the medication may degrade or lose potency before its expiration date. This could result in the topical steroid being less effective than intended for treating skin conditions.

What You Should Do

This recall affects Clobetasol Propionate Lotion 0.05% (118 mL bottles), which is a generic version of Temovate sold under the Preferred Pharmaceuticals, Inc. and The Physician's Solution brands.
Affected products are labeled with NDC 68788-7768-01 and have specific lot numbers printed on the bottle. See the Affected Products section below for the full list of affected codes.
If you have health concerns about using this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Preferred Pharmaceuticals, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clobetasol Propionate Lotion 0.05%, Generic for Temovate (118 mL)

Variants: 0.05%, Lotion

Lot Numbers:

A0721O (Exp 4/30/2022)

A1421Y (Exp 4/30/2022)

A2121G (Exp 4/30/2022)

A2821D (Exp 4/30/2022)

B0421H (Exp 4/30/2022)

B0421I (Exp 4/30/2022)

B0521U (Exp 4/30/2022)

B1121G (Exp 4/30/2022)

B1921C (Exp 4/30/2022)

C0421B (Exp 4/30/2022)

C1821N (Exp 4/30/2022)

L0120F (Exp 4/30/2022)

L2320O (Exp 4/30/2022)

L3020T (Exp 4/30/2022)

B2521A (Exp 10/31/2022)

C1121S (Exp 10/31/2022)

C2521U (Exp 10/31/2022)

D0121S (Exp 10/31/2022)

D0921B (Exp 10/31/2022)

D1421B (Exp 10/31/2022)

D2921C (Exp 10/31/2022)

E0721A (Exp 10/31/2022)

D2221A (Exp 12/31/2022)

NDC:

68788-7768-01

Manufactured by Teligent Pharma, Inc. All products within expiry are being recalled.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89924

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 1568 bottles

Distributed To: Illinois

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Clobetasol Propionate Lotion 0.05% (118 mL bottles), which is a generic version of Temovate sold under the Preferred Pharmaceuticals, Inc. and The Physician's Solution brands.

Affected products are labeled with NDC 68788-7768-01 and have specific lot numbers printed on the bottle. See the Affected Products section below for the full list of affected codes.

If you have health concerns about using this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Preferred Pharmaceuticals, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clobetasol Propionate Lotion 0.05%, Generic for Temovate (118 mL)

Variants: 0.05%, Lotion

Lot Numbers:

A0721O (Exp 4/30/2022)

A1421Y (Exp 4/30/2022)

A2121G (Exp 4/30/2022)

A2821D (Exp 4/30/2022)

B0421H (Exp 4/30/2022)

B0421I (Exp 4/30/2022)

B0521U (Exp 4/30/2022)

B1121G (Exp 4/30/2022)

B1921C (Exp 4/30/2022)

C0421B (Exp 4/30/2022)

C1821N (Exp 4/30/2022)

L0120F (Exp 4/30/2022)

L2320O (Exp 4/30/2022)

L3020T (Exp 4/30/2022)

B2521A (Exp 10/31/2022)

C1121S (Exp 10/31/2022)

C2521U (Exp 10/31/2022)

D0121S (Exp 10/31/2022)

D0921B (Exp 10/31/2022)

D1421B (Exp 10/31/2022)

D2921C (Exp 10/31/2022)

E0721A (Exp 10/31/2022)

D2221A (Exp 12/31/2022)

NDC:

68788-7768-01

Manufactured by Teligent Pharma, Inc. All products within expiry are being recalled.