PlainRecalls
FDA Drug Moderate Class II Ongoing

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64

Reported: May 11, 2022 Initiated: April 21, 2022 #D-0848-2022

Product Description

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64

Reason for Recall

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Details

Units Affected
81,757 bottles
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64. Recalled by McKesson Corporation dba McKesson Drug Company. Units affected: 81,757 bottles.
Why was this product recalled? ▼
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0848-2022.

Related Recalls

CPSC Moderate

Huaker Magnetic Balls and Rods Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violates the Small Ba…

Shenzhen Huakechuang Technology Co. Ltd., dba Huaker, of China · 2026-02-19
CPSC Moderate

JJGoo LED Balloon Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Sta…

Shenzhen Yimu Technology Co., Ltd. dba JJGoo, of China · 2026-02-19
CPSC Moderate

Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labe…

Joly's LLC, of Orlando, Florida · 2026-02-19
CPSC Moderate

Prismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Sta…

Prismatic 3D Prints LLC of Loveland, Colorado · 2026-02-19
CPSC Moderate

SAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory …

Shenzhenshilonghuaqujialebeibaihuoshanghang (Jialebei Department Store, Longhua District, Shenzhen) dba Samit Outdoor, of China · 2026-02-19

Explore Related Data

Vehicle Safety → Drug Information →