Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon Recalls

All product recalls associated with Glaxosmithkline Consumer Healthcare Holdings DBA Haleon.

Get alerts for this brand

Recall Summary

Total Recalls

559

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 559 recalls

Advil Liqui-Gels Minis (Haleon) – Illegible Label (2022)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Class IHigh

FDADec 6, 2022Nationwide• Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Advil Liqui-Gels (Haleon) – Illegible Label (2022)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Class IHigh

FDADec 6, 2022Nationwide• Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Advil Tablets 200mg (Haleon) – Illegible Label (2022)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

1...4 567 8...28

Page 6 of 28Next

Class IHigh

FDADec 6, 2022Nationwide• Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

TUMS Antacid Berries (GSK) – Glass Mineral Contamination (2022)

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Class IIModerate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

TUMS Antacid Peppermint (GSK) – Glass Mineral Contamination (2022)

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Class IIModerate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

Smiths Medical ASD Inc.: Medfusion Model 4000 Syringe Infusion Pump, with software...

Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

FDAOct 10, 2022IN, TX, VA• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, ...

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

FDAJun 27, 2022Nationwide• Smith & Nephew, Inc.

2022 C.E. SMITH COMPANY MULTI-SPORT 48810 Recall: SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY

C.E. Smith Company, Inc. (C.E. Smith) is recalling certain 2021-2022 C.E. Smith Company Multi-Sport 48810 and 48815, Multi-Sport Plus 48870, Malone Auto Racks MicroSport MPG460, and EcoLight MPG585 boat trailers. The weld connecting the axle tube to the wheel spindle may fail, causing the wheel to separate from the trailer.

NHTSAJun 7, 2022Nationwide• C.E. SMITH COMPANY

Tivicay (GlaxoSmithKline) - Incorrect Labeling (2022)

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

Class IIILow

FDAMay 13, 2022Nationwide• GlaxoSmithKline LLC

Smith & Nephew Orthopaedics GmbH Alemannenstr. 14 Tuttlingen Germany: INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 ...

Right nails were anodized, marked, and labelled as left nails and vice versa

FDAApr 22, 2022Nationwide• Smith & Nephew Orthopaedics GmbH Alemannenstr. 14 Tuttlingen Germany

Smith & Nephew Inc: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OX...

It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

FDAApr 19, 2022Nationwide• Smith & Nephew Inc

Smiths Medical ASD Inc.: Medfusion Syringe Pump Model: Model 4000-0100-50, Model ...

Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001

FDAApr 18, 2022Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-...

FDAApr 18, 2022Nationwide• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

FDAJan 4, 2022Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Acufex Access Advanced Positioning Kit - indicated for us...

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

FDADec 14, 2021Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, ...

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

FDANov 1, 2021Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM,...

FDANov 1, 2021Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1...

The labels on the packages of screws were switched.

FDAOct 25, 2021AL, AZ, CA +22 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: 6.5MMX165MM CANNULATED SCREW

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

FDASep 20, 2021Nationwide• Smith & Nephew, Inc.

Smiths Medical ASD Inc.: Bivona Aire-Cuf Endotracheal Tube

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

FDAAug 9, 2021Nationwide• Smiths Medical ASD Inc.