Medications & Supplements/Topical Products

McKesson Topical Ointments and Solutions Recalled for Quality Standards

Agency Publication Date: May 5, 2022

Summary

McKesson Drug Company is recalling approximately 144,026 tubes and bottles of various prescription topical medications, including Halobetasol Propionate, Lidocaine, Betamethasone, and Erythromycin. These products are being recalled because the manufacturing firm, Teligent Pharma, Inc., is discontinuing its stability study program, which means the drugs' quality and effectiveness cannot be guaranteed through their expiration dates. This is a voluntary recall initiated by the firm due to deviations from current good manufacturing practices.

Risk

Without ongoing stability studies, there is no assurance that these medications will maintain their intended potency and safety through their printed expiration dates. Using a drug that has degraded may result in ineffective treatment for your skin condition or medical procedure.

What You Should Do

This recall affects Halobetasol Propionate Ointment, Lidocaine Hydrochloride Solution, Lidocaine Prilocaine Cream, Betamethasone Dipropionate Ointment, and Erythromycin Topical Gel distributed by McKesson under the Sky Packaging label.
Check your medication packaging for NDC numbers 63739-998-67, 63739-977-64, 63739-054-66, 63739-996-65, or 63739-053-68. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: Halobetasol Propionate Ointment 0.05% (50 gram tube)

Variants: Ointment, 0.05%

Lot Numbers:

15720 (Exp. 06/30/2022)

16449 (Exp. 02/28/2023)

16450 (Exp. 02/26/2023)

NDC:

63739-998-67

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Lidocaine Hydrochloride Topical Solution USP 4% (50 mL bottle)

Variants: Topical Solution, 4%, 40 mg/mL

Lot Numbers:

15597 (Exp. 05/31/2023)

16305 (Exp. 12/23/2023)

16334 (Exp. 01/31/2024)

16340 (Exp. 01/31/2024)

16346 (Exp. 01/31/2024)

16356 (Exp. 01/31/2024)

16357 (Exp. 01/31/2024)

NDC:

63739-977-64

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Lidocaine Prilocaine Cream USP 2.5%/2.5% (30 gram tube)

Variants: Cream, 2.5%/2.5%

Lot Numbers:

16876 (Exp. 05/31/2023)

NDC:

63739-054-66

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Betamethasone Dipropionate Ointment USP 0.05% (Augmented) (15 gram tube)

Variants: Ointment, 0.05%

Lot Numbers:

15644 (Exp. 05/31/2022)

NDC:

63739-996-65

Potency expressed as betamethasone; Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Erythromycin Topical Gel USP 2% (60 gram tube)

Variants: Topical Gel, 2%

Lot Numbers:

15723 (Exp. 06/30/2022)

NDC:

63739-053-68

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89986

Status: Active

Manufacturer: McKesson Corporation dba McKesson Drug Company

Sold By: McKesson Drug Company; Sky Packaging

Manufactured In: United States

Units Affected: 5 products (13, 200 tubes; 81,757 bottles; 1176 tubes; 55,440 tubes; 5,640 tubes)

Distributed To: Nationwide

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 Halobetasol Propionate Ointment, Lidocaine Hydrochloride Solution, Lidocaine Prilocaine Cream, Betamethasone Dipropionate Ointment, and Erythromycin Topical Gel distributed by McKesson under the Sky Packaging label.

Check your medication packaging for NDC numbers 63739-998-67, 63739-977-64, 63739-054-66, 63739-996-65, or 63739-053-68. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: Halobetasol Propionate Ointment 0.05% (50 gram tube)

Variants: Ointment, 0.05%

Lot Numbers:

15720 (Exp. 06/30/2022)

16449 (Exp. 02/28/2023)

16450 (Exp. 02/26/2023)

NDC:

63739-998-67

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Lidocaine Hydrochloride Topical Solution USP 4% (50 mL bottle)

Variants: Topical Solution, 4%, 40 mg/mL

Lot Numbers:

15597 (Exp. 05/31/2023)

16305 (Exp. 12/23/2023)

16334 (Exp. 01/31/2024)

16340 (Exp. 01/31/2024)

16346 (Exp. 01/31/2024)

16356 (Exp. 01/31/2024)

16357 (Exp. 01/31/2024)

NDC:

63739-977-64

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Lidocaine Prilocaine Cream USP 2.5%/2.5% (30 gram tube)

Variants: Cream, 2.5%/2.5%

Lot Numbers:

16876 (Exp. 05/31/2023)

NDC:

63739-054-66

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Betamethasone Dipropionate Ointment USP 0.05% (Augmented) (15 gram tube)

Variants: Ointment, 0.05%

Lot Numbers:

15644 (Exp. 05/31/2022)

NDC:

63739-996-65

Potency expressed as betamethasone; Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Product: Erythromycin Topical Gel USP 2% (60 gram tube)

Variants: Topical Gel, 2%

Lot Numbers:

15723 (Exp. 06/30/2022)

NDC:

63739-053-68

Manufactured by Teligent Pharma, Inc.; Distributed by Sky Packaging

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89986

Status: Active

Manufacturer: McKesson Corporation dba McKesson Drug Company

Sold By: McKesson Drug Company; Sky Packaging

Manufactured In: United States

Units Affected: 5 products (13, 200 tubes; 81,757 bottles; 1176 tubes; 55,440 tubes; 5,640 tubes)

Distributed To: Nationwide