Sensodyne Paste
FDA Recall NDC 0135-0548

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 3 recorded enforcement report(s) associated with Sensodyne (NDC 0135-0548). A significant event, classified as Class II, was initiated on Mar 06, 2017 by Haleon Us Holdings Llc. The reported reason for this action was: "Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0624-2017TERMINATEDD-1323-2015TERMINATEDD-1324-2015TERMINATED

March 2017 Class II Recall: Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent

Recall Number
D-0624-2017
Class II Terminated
Reason for Recall
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Initiated
Mar 06, 2017
Reported
Apr 05, 2017
Quantity
56,840 cases

Recall Profile & Regulatory Data

Event ID
76662
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GSK Consumer Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 31, 2018
Product Description
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
Batch or Lot Expiration Information
Lot# A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018
Affected Packages Involved in this Recall
0135-0548-02Product
0135-0548-01Product
0135-0547-02Product
0135-0575-01Product

July 2015 Class II Recall: Presence of Foreign Substance

Recall Number
D-1323-2015
Class II Terminated
Reason for Recall
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Initiated
Jul 15, 2015
Reported
Aug 19, 2015
Quantity
335,676 tubes

Recall Profile & Regulatory Data

Event ID
71750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithkline Consmer Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico & Taiwan
Termination Date
Apr 19, 2017
Product Description
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02
Batch or Lot Expiration Information
Lot# Q3H061, Q3H081, Q3H101, Q3H131, Exp 07/15 Q3J101, Q3J121, Q3J261, Q3J291, Exp 08/15 Q3K161, Q3K181, Q3K211, Q3M021, Exp 09/15 Q3M071, QEM251, Exp 10/15 Q3N021, Q3N211, Exp 11/15 Q4A071, Q4A111, Q4A251, Q4B201, Exp 12/15 Q4C151, Q4C191, Exp 12/16 Q4D111, Q4D151, Q4D151R, Exp 03/16 Q4E151, Q4E151R, Q3E152, Exp 04/16 Q4F161, Q4F201, Exp 05/16 Q4G271, Q4G301, Exp 06/16 Q4J051, Exp 08/16
Affected Packages Involved in this Recall
0135-0548-02Product
0135-0548-01Product
0135-0547-02Product
0135-0575-01Product

July 2015 Class II Recall: Presence of Foreign Substance

Recall Number
D-1324-2015
Class II Terminated
Reason for Recall
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Initiated
Jul 15, 2015
Reported
Aug 19, 2015
Quantity
325,504 tubes

Recall Profile & Regulatory Data

Event ID
71750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithkline Consmer Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico & Taiwan
Termination Date
Apr 19, 2017
Product Description
SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Batch or Lot Expiration Information
Lot# a) R3J181, Exp 08/15 R4A191, R4A192, R41291, R4B011, Exp 12/15 R4C111, Exp 02/16
Lot# b) R3G291, R3H011, Exp 06/15 R3H191, R3H261, R3H291, Exp 07/15 R3J171, R3J182, R3J191, R3J241, Exp 08/15 R3K031, R3K121, R3K221, R3K291, Exp 09/15 R3M111, R3M181, Exp 10/15 R3N081, R3N101, Exp 11/15 R4A211, Exp 12/15 R4B281, Exp 01/16 R4C041, R4C291, R4D021, Exp 02/16 R4D081, Exp 03/16 R4E231, Exp 04/16 R4F081, Exp 05/16 R4G191, Exp 06/16 R4H031, R4H071, R4H271, Exp 07/16
Affected Packages Involved in this Recall
0135-0548-02Product
0135-0548-01Product
0135-0547-02Product
0135-0575-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.