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
/
Upsher Smith Laboratories, Inc.

Upsher Smith Laboratories, Inc. Recalls

All product recalls associated with Upsher Smith Laboratories, Inc..

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 241–260 of 559 recalls

Bexarotene Capsules (Upsher Smith) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2019KY, LA, NJ +1 more• Upsher Smith Laboratories, Inc.

Smiths Medical ASD Inc.: GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUM...

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

FDAJul 8, 2019Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: GRIPPER Needles sold individually. Labeled as the follow...

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

FDAJul 8, 2019Nationwide

1...11 121314 15...28

Page 13 of 28Next

• Smiths Medical ASD Inc.

30-Gallon Gas Water Heater (A.O. Smith) – fire hazard (2018)

Fire/Burn Risk

This recall includes A. O. Smith 30-gallon natural gas water heaters with model number G6-UT3030NV and serial numbers with the first four digits of 1805 through 1809. A. O. Smith, the model number and the serial number are printed on the data plate located next to the gas water heater's control valve/thermostat. A. O. Smith is printed near the top of the water heater.

CPSCNov 8, 2018Nationwide• A. O. Smith Corp., of Milwaukee, Wis.

Ultra-Low NOx Water Heaters (A.O. Smith) – fire risk (2018)

Fire/Burn Risk

This recall includes 30, 40 and 50 gallon natural or propane gas-fired Ultra-Low NOx emission gas water heaters. They are designed to comply with regulations in certain air quality districts in California, and were sold primarily in California. They were sold under the American, A. O. Smith, Kenmore, Reliance, State, U.S. Craftsmaster and Whirlpool brand names and manufactured from April 8, 2011 through August 1, 2016. Only water heaters with the first four digit serial numbers between 1115 and 1631, where the first four digits represent the year and week of production, are included in the recall. The brand name, model number and serial number can be found on the data plate on the product located next to the gas control valve/thermostat. The brand name is printed near the top of the water heater. Consumers can look up their water heater's serial number to see if it is affected by this recall at www.waterheaterrecall.com.

CPSCNov 8, 2018Nationwide• A. O. Smith Corp., of Milwaukee, Wis.

Prevacid 24HR (GlaxoSmithKline) – CGMP Deviation (2018)

CGMP deviations

Class IIModerate

FDASep 26, 2018Nationwide• GLAXOSMITHKLINE NEBRASKA

Bumetanide 2mg (Upsher Smith) – Impurity Specification (2018)

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Class IIModerate

FDASep 19, 2018Nationwide• Upsher Smith Laboratories, Inc.

Bumetanide 1mg (Upsher Smith) – Impurity Specification (2018)

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Class IIModerate

FDASep 19, 2018Nationwide• Upsher Smith Laboratories, Inc.

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Ventolin HFA Inhaler (GlaxoSmithKline) – Delivery System Defect (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Class IIModerate

FDAMay 16, 2017Nationwide• GlaxoSmithKline, LLC

Ventolin HFA (GlaxoSmithKline) – Defective Delivery System (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Class IIModerate

FDAMar 22, 2017Nationwide• GlaxoSmithKline, LLC

Bactroban Nasal (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Bactroban Ointment (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Ventolin HFA Inhaler (GlaxoSmithKline) – Insufficient Propellant (2015)

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

Class IIModerate

FDADec 3, 2015MS, VT• GlaxoSmithKline, LLC

Gouda with Bacon Spread (Smith's) – E. Coli contamination (2015)

E. coli

Contaminated with non pathogenic E. Coli

Class IIILow

FDANov 24, 2015GA, MA, NH• Smith's Country Cheese, Inc.