Tums Tablet, Chewable
FDA Recall NDC 0135-0180
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Tums (NDC 0135-0180). A significant event, classified as Class II, was initiated on Dec 02, 2022 by Haleon Us Holdings Llc. The reported reason for this action was: "Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Dec 02, 2022
Nov 08, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93255
Classification
Class II
Enforcement Status
Completed
Recalling Firm
GlaxoSmithKline Consumer Healthcare Holdings LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
Batch or Lot Expiration Information
Lot# : KH5L, Exp. Date 09/30/2027
Affected Packages Involved in this Recall
0135-0118-01Product
0135-0118-04Product
0135-0118-14Product
0135-0118-83Product
0135-0180-01Product
0135-0180-02Product
0135-0180-14Product
0135-0181-01Product
0135-0181-02Product
0135-0181-03Product
0135-0181-05Product
0135-0181-06Product
0135-0181-07Product
0135-0181-14Product
0135-0228-01Product
0135-0228-04Product
0135-0228-05Product
0135-0228-06Product
0135-0228-07Product
0135-0540-01Product
0766-0746-50Product
Class II Completed
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Dec 02, 2022
Nov 08, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93255
Classification
Class II
Enforcement Status
Completed
Recalling Firm
GlaxoSmithKline Consumer Healthcare Holdings LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
Batch or Lot Expiration Information
Lot# : HB2G, Exp. Date 8/31/2027
Affected Packages Involved in this Recall
0135-0118-01Product
0135-0118-04Product
0135-0118-14Product
0135-0118-83Product
0135-0180-01Product
0135-0180-02Product
0135-0180-14Product
0135-0181-01Product
0135-0181-02Product
0135-0181-03Product
0135-0181-05Product
0135-0181-06Product
0135-0181-07Product
0135-0181-14Product
0135-0228-01Product
0135-0228-04Product
0135-0228-05Product
0135-0228-06Product
0135-0228-07Product
0135-0540-01Product
0766-0745-85Product
Class II Completed
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Dec 02, 2022
Nov 08, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93255
Classification
Class II
Enforcement Status
Completed
Recalling Firm
GlaxoSmithKline Consumer Healthcare Holdings LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
Batch or Lot Expiration Information
Lot# : HA7G, Exp. Date 8/31/2027
Affected Packages Involved in this Recall
0135-0118-01Product
0135-0118-04Product
0135-0118-14Product
0135-0118-83Product
0135-0180-01Product
0135-0180-02Product
0135-0180-14Product
0135-0181-01Product
0135-0181-02Product
0135-0181-03Product
0135-0181-05Product
0135-0181-06Product
0135-0181-07Product
0135-0181-14Product
0135-0228-01Product
0135-0228-04Product
0135-0228-05Product
0135-0228-06Product
0135-0228-07Product
0135-0540-01Product
0766-0746-80Product
Class II Completed
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Dec 02, 2022
Nov 08, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93255
Classification
Class II
Enforcement Status
Completed
Recalling Firm
GlaxoSmithKline Consumer Healthcare Holdings LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
Batch or Lot Expiration Information
Lot# : HV6B, Exp. Date 9/30/2027
Affected Packages Involved in this Recall
0135-0118-01Product
0135-0118-04Product
0135-0118-14Product
0135-0118-83Product
0135-0180-01Product
0135-0180-02Product
0135-0180-14Product
0135-0181-01Product
0135-0181-02Product
0135-0181-03Product
0135-0181-05Product
0135-0181-06Product
0135-0181-07Product
0135-0181-14Product
0135-0228-01Product
0135-0228-04Product
0135-0228-05Product
0135-0228-06Product
0135-0228-07Product
0135-0540-01Product
0766-0746-10Product
Class III Terminated
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Jul 18, 2013
Aug 14, 2013
300,480 bottles
Recall Profile & Regulatory Data
Event ID
65856
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
May 18, 2016
Product Description
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
Batch or Lot Expiration Information
Lot# Lot 3C11 and 3C11A
Affected Packages Involved in this Recall
0135-0118-01Product
0135-0118-04Product
0135-0118-14Product
0135-0118-83Product
0135-0180-01Product
0135-0180-02Product
0135-0180-14Product
0135-0181-01Product
0135-0181-02Product
0135-0181-03Product
0135-0181-05Product
0135-0181-06Product
0135-0181-07Product
0135-0181-14Product
0135-0228-01Product
0135-0228-04Product
0135-0228-05Product
0135-0228-06Product
0135-0228-07Product
0135-0540-01Product
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.
