CLASS II Drug recall · Reported 8 Nov 2023 · FDA Enforcement Report
TUMS Antacid, Calcium Carbonate USP 1000 mg recalled
GlaxoSmithKline Consumer Healthcare Holdings is recalling TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, distributed nationwide in the US. The recall was initiated on 2 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0073-2024
- FDA event ID
- 93255
- Recalling firm
- GlaxoSmithKline Consumer Healthcare Holdings, Saint Louis, MO
- Brand
- Tums
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Dec 2022
- FDA classified
- 27 Oct 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 2 Dec 2022 | Recall initiated by company | |
| 27 Oct 2023 | Classified by FDA | +329 days |
| 8 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Which lots are affected?
Lot#: HB2G, Exp. Date 8/31/2027
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 93255This product is part of a recall event; the main page for the event is TUMS Antacid, Calcium Carbonate USP 1000 mg recalled.
More recalls from GlaxoSmithKline Consumer Healthcare Holdings
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalled | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
| Drug | CLASS II | TUMS Antacid, Calcium Carbonate USP 1000 mg recalledTums | GlaxoSmithKline Consumer Healthcare Holdings | Foreign Material | Nationwide |
Other Calcium Carbonate recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kirkland Signature, Ultra Strength Antacid recalled by Guardian Drug CoKirkland Ultra Stregth Antacid 171ab | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, extra strength Antacid Calcium recalledGood Neighbor Pharmacy Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | H.E.B Extra Strength Calcium Carbonate Antacid Tablets recalledHeb Extra Stregth Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Family Wellness, Ultra Strengt, Antacid Tablets recalledFamily Wellness Ultra Strength Assorted Fruit Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | TopCare health, Extra Strength, Antacid Tablets recalledTopcare Extra Strength Antacid | Guardian Drug | Particulate Matter | Nationwide |