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GlaxoSmithKline, LLC.

GlaxoSmithKline, LLC. Recalls

All product recalls associated with GlaxoSmithKline, LLC..

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Recall Summary

Total Recalls

573

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 321–340 of 573 recalls

Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Class IIILow

FDAOct 24, 2012Nationwide• GlaxoSmithKline, LLC.

Arranon Injection (GlaxoSmithKline) – Impurity Concerns (2012)

Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.

Class IIModerate

FDAOct 8, 2012Nationwide• GlaxoSmithKline, LLC.

Peanut Butter Ice Cream (Smith Dairy) – Ingredient Concern (2012)

The firm was notified by their supplier, Pecan Deluxe, Dallas, TX, that the peanut butter crunch candies that was purchase for use in their ice cream were made using peanut butter supplied from Sunland, Inc.

1...15 161718 19...29

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Class IHigh

FDAOct 5, 2012IN, MI, OH +1 more• Smith Dairy Products Co

Peanut Butter Brownie Crunch (Smith Dairy) – Ingredient Concern (2012)

Class IHigh

FDAOct 5, 2012IN, MI, OH +1 more• Smith Dairy Products Co

Ventolin HFA Inhaler (GlaxoSmithKline) – Improper Dose (2012)

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Class IIModerate

FDAJul 26, 2012Nationwide• GlaxoSmithKline Inc

Trizivir Tablets (GlaxoSmithKline) – Tablet Contamination (2012)

Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.

Class IIModerate

FDAJun 4, 2012Nationwide• GlaxoSmithKline Inc

SMI PROLO Equipment Recall: STRUCTURE:BODY:ROOF AND PILLARS

SPECIALTY MANUFACTURING, INC. (SMI) IS RECALLING CERTAIN PROLO BUS ROOF ESCAPE HATCHES INSTALLED AS ORIGINAL EQUIPMENT ON VARIOUS SCHOOL AND TRANSIT BUSES SHIPPED FROM APRIL 1, 2011, THROUGH MARCH 25, 2012. THESE HATCHES MAY HAVE ALSO BEEN USED AS SERVICE REPLACEMENT PARTS. INCREASED FRICTION BETWEEN THE REAR PLATE ASSEMBLIES, P/NO. 009327, AND THE NYLON REAR POP-UP SUPPORT, P/NO. 008956, MAY RESULT IN AN OPENING FORCE OF THE PROLO ROOF HATCHES THAT EXCEEDS FEDERAL STANDARD REQUIREMENTS. THUS, THESE HATCHES FAIL TO CONFORM TO THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 217, "BUS EMERGENCY EXITS AND WINDOW RETENTION AND RELEASE."

NHTSAMay 7, 2012Nationwide• SMI

Smiths Medical ASD, Inc.: CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF...

The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.

FDADec 23, 2009MI• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Smiths Medical Medfusion model 3010a syringe Infusion pum...

Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its so

FDANov 16, 2009AL, AK, AZ +44 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Smiths Medical Medfusion model 3500 syringe Infusion pump...

FDANov 16, 2009AL, AK, AZ +44 more• Smiths Medical ASD, Inc.

Smith & Nephew, Inc., Endoscopy Div.: AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716...

Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.

FDASep 3, 2009Nationwide• Smith & Nephew, Inc., Endoscopy Div.

Smith & Nephew, Inc., Endoscopy Div.: AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 7220171...

Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.

FDASep 3, 2009Nationwide• Smith & Nephew, Inc., Endoscopy Div.

Smith & Nephew, Inc., Endoscopy Div.: AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716...

Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.

FDASep 3, 2009Nationwide• Smith & Nephew, Inc., Endoscopy Div.

Smiths Medical Hythe Hythe, Kent United Kingdom: Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2...

Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway

FDAAug 25, 2009Nationwide• Smiths Medical Hythe Hythe, Kent United Kingdom

Smiths Medical Hythe Hythe, Kent United Kingdom: Portex Polar Preformed Tracheal Tube, South Oral, Murphy ...

Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway

FDAAug 25, 2009Nationwide• Smiths Medical Hythe Hythe, Kent United Kingdom

Smiths Medical Hythe Hythe, Kent United Kingdom: Portex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm Pro...

Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway

FDAAug 25, 2009Nationwide• Smiths Medical Hythe Hythe, Kent United Kingdom

Smiths Medical Hythe Hythe, Kent United Kingdom: Portex Uncuffed Paediatric Sized Tracheal Tube, Oral Nasa...

Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway

FDAAug 25, 2009Nationwide• Smiths Medical Hythe Hythe, Kent United Kingdom

Smiths Medical ASD, Inc.: Portex Continuous Epidural Tray, Reference 4037-20 An an...

Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.

FDAJul 15, 2009Nationwide• Smiths Medical ASD, Inc.

Smith's Lemon Iced Tea (Smith Dairy) – Undeclared Milk (2009)

Undeclared Allergen

The firm distributed liquid lemon-flavored tea which contained milk residue (undeclared dairy).

Class IHigh

FDAJun 16, 2009IN, OH• Smith Dairy Products Co

Smith & Nephew Inc: Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part ...

Problems with transducer may result in a reduced ultrasound output.

FDAJun 5, 2009Nationwide• Smith & Nephew Inc