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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

GlaxoSmithkline Consmer Healthcare: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Agency Publication Date: August 11, 2015
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Affected Products

Product: biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

Lot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16

Lot Numbers:
Y2J101
Product: biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

Lot # a) X3G121, X3H141, Exp 06/16 X3K121, Exp 09/16 X4D281, Exp 03/17 X4G181, Exp 06/17 b) X3C041, Exp 01/16 c) X3F032, Exp 04/16 X3G101, X3G131, Exp 06/16 X3H171, X3H211, X3H291, Exp 07/16 X3J271, Exp 08/16 X3K021, X3K171, X3K291, Exp 09/16 X3M121, Exp 10/16 X3N171, Exp 11/16 X4B061, X4B081, Exp 01/17 X4C121, X4C251, Exp 02/17 X4D291, X4D301, Exp 03/17 X4E081, X4G131, Exp 04/17 X4H111, Exp 06/17 d) X2H021, Exp 07/15 X2K151, X2K231 Exp 09/15 X3B211,X3C012, X3C011, Exp 01/16 X3C141, X3C251, Exp 02/16 X3G021, Exp 06/16

Product: biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01

Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y4C271, Exp 02/17 Y4E131, Exp 04/17 Y4G101, Exp 05/17 Y4H191, Exp 06/17

Lot Numbers:
Y3E211
Product: biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

Lot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16

Product: SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 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 0135-0572-02

Lot # C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16

Lot Numbers:
C4D061
Product: SENSODYNE COMPLETE PROTECTION, 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 0135-0573-02

Lot # B4D031, Exp 03/16 B4E101, Exp 04/16 B4F261,B4F291,B4G011, Exp 05/16 B4G031, B4G091, Exp 06/16 B4J031, Exp 07/16

Lot Numbers:
B4D031
Product: 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

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

Lot Numbers:
Q3H061
Product: 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

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71750
Status: Resolved
Manufacturer: GlaxoSmithkline Consmer Healthcare
Manufactured In: United States
Units Affected: 8 products (30,516 tubes; 366,192 tubes; 111,892 tubes; 50,860 tubes; 50,860 tubes; 81,376 tubes; 335,676 tubes; 325,504 tubes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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