CLASS III Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Tums, Antacid/Calcium Supplement, Ultra Strength recalled
GlaxoSmithKline is recalling Tums, Antacid/Calcium Supplement, Ultra Strength 1000, Assorted Berries, GlaxoSmithKline, distributed nationwide in the US. The recall was initiated on 18 Jul 2013 and the FDA has classified it as Class III.
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-850-2013
- FDA event ID
- 65856
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jul 2013
- FDA classified
- 7 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 18 Jul 2013 | Recall initiated by company | |
| 7 Aug 2013 | Classified by FDA | +20 days |
| 14 Aug 2013 | Published in enforcement report | +7 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 Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Product as listed by the FDA
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Which lots are affected?
Lot 3C11 and 3C11A
Where was it sold?
U.S. Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 11 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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