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GlaxoSmithkline Consmer Healthcare

GlaxoSmithkline Consmer Healthcare Recalls

All product recalls associated with GlaxoSmithkline Consmer Healthcare.

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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 281–300 of 559 recalls

Panadol Extra Strength (GlaxoSmithKline) – dissolution failure (2015)

Failed Dissolution Specifications

Class IIILow

FDAJun 30, 2015PR• GlaxoSmithkline Consmer Healthcare

John Wood Oil-Fired Water Heaters (A.O. Smith) - Fire risk (2015)

Fire/Burn Risk

This recall involves John Wood brand 50- and 70-gallon oil-fired water heaters. The 50-gallon water heaters have model number JW517 and serial numbers from 1349A021678 through 1503A016643. The 70-gallon water heaters have model number JW717 and serial numbers from 1421M001517 through 436M000040. The water heaters are gray with "John Wood" printed in blue and white near the top. The model number, size and serial numbers are printed on the rating plate near the top of the tank. Only oil-fired water heaters are included in this recall.

CPSCJun 2, 2015Nationwide• A.O. Smith Corp., of Milwaukee, Wis.

Smith's Carrot Cake (Smith's Food) - incomplete ingredient statement (2015)

1...13 141516 17...28

Page 15 of 28Next

Firm discovered a Carrot Cake scale label that did not print the ingredient statement in its entirety and failed to include the allergen statement "CONTAINS: WHEAT, MILK & SOY, EGGS, WALNUTS, RAISINS."

Class IHigh

FDAApr 2, 2015AZ, ID, MT +4 more• Smith's Food And Drug, Inc

Smiths Medical ASD, Inc.: Portex Anaerobic Pulsator Arterial Blood Sampling Kit, wi...

The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

Class IIILow

FDADec 17, 2014FL, IN• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 2...

Needle is not captured in the needle safety sheath in specific lots.

Class IIModerate

FDANov 21, 2014Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 2...

Needle is not captured in the needle safety sheath in specific lots.

Class IIModerate

FDANov 21, 2014Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorde...

Needle is not captured in the needle safety sheath in specific lots.

Class IIModerate

FDANov 21, 2014Nationwide• Smiths Medical ASD, Inc.

Smith & Nephew, Inc.: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RI...

The stem taper on this device is undersized; the gauge point is not deep enough.

Class IIModerate

FDANov 4, 2014Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LE...

The stem taper on this device is undersized; the gauge point is not deep enough.

Class IIModerate

FDANov 4, 2014Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LE...

The stem taper on this device is undersized; the gauge point is not deep enough.

Class IIModerate

FDANov 4, 2014Nationwide• Smith & Nephew, Inc.

Smiths Medical ASD, Inc.: CADD-Solis Medication Safety Software, Administrator CD, ...

Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.

Class IIModerate

FDASep 29, 2014Nationwide• Smiths Medical ASD, Inc.

Smith & Nephew, Inc.: RENASYS EZ Negative Pressure Wound Therapy (NPWT) System ...

Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

Class IIModerate

FDAAug 13, 2014Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifi...

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) wit...

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifi...

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

Panadol Advance (GSK) – Closure Failure (2014)

This recall involves bottles of 100ct Panadol Advance pain relievers. The medicine was sold in white containers with a blue label, inside a blue box. "Panadol" and "Advance" are printed on the label. Lot numbers and dates codes are located on the left side panel of the box and on the left side of the label on the bottle, near the bar code. Lot numbers and date codes included in the recall are: Lot number: 14241, expiration date: 02/2015 Lot number: 14002, expiration date: 10/2014 Lot number: 13881, expiration date: 09/2014 Lot number: 13801, expiration date: 09/2014

CPSCJul 14, 2014Nationwide• GlaxoSmithKline (GSK), of Moon Township, Penn.

Gouda Cheese Wheels (Smith's) – Listeria Risk (2014)

Listeria

Product contaminated with Listeria monocytogenes

Class IHigh

FDAJun 12, 2014MA• Smith's Country Cheese, Inc.

Oxandrolone Tablets (Upsher Smith) – missing primary label (2014)

Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.

Class IIILow

FDAApr 14, 2014Nationwide• Upsher Smith Laboratories, Inc.

Nicorette & NicoDerm CQ (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Class IIILow

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Nicorette Product Line (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Class IIILow

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline