HIGHFDA DRUG

GOLD STAR DISTRIBUTION TUMS 12-Count Recall 2026 for Rodent-Contamination CGMP Deviations

Gold Star Distribution is recalling TUMS Assorted 12-count products sold nationwide through various retailers after CGMP deviations linked to insanitary conditions and rodent exposure at the distribution center. The recall covers three SKUs: 1194A with expiry 05/27 and 1194C with expiry 03/27, plus the Assorted 12-count variant. Consumers should stop using the product immediately and contact Gold

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 26, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 26, 2025
Hazard Level
HIGH
Brand
GOLD STAR DISTRIBUTION
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
GOLD STAR DISTRIBUTION
Product type
Calcium carbonate tablets (antacid)
Model numbers
1194A, 1194C
Sizes
12-count
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 26, 2025

  2. Reported by FDA DRUG

    January 21, 2026

  3. RecallRadar source check

    March 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact GOLD STAR DISTRIBUTION INC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

About This Product

TUMS is an over-the-counter calcium carbonate antacid used to relieve heartburn and indigestion. The product is sold in 12-count carton formats and appears in assorted berry and fruit flavors.

Why This Is Dangerous

The recall cites insanitary conditions and rodent exposure at the distribution center as the defect. Contamination risk could affect the safety and quality of the product.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers may need to discard affected product and seek refunds. There is potential health risk if contaminated products are consumed.

Practical Guidance

How to identify if yours is affected

  1. Check for SKUs 1194A and 1194C on packaging.
  2. Verify expiry dates 05/27 for 1194A and 03/27 for 1194C.
  3. Confirm distributor label: Gold Star Distribution.

Where to find product info

Product labels and cartons display SKUs, expiry dates, and distributor information. Recall notices from the FDA provide details.

What timeline to expect

Refunds or replacements typically take 4-8 weeks once processed.

If the manufacturer is unresponsive

  • Document all communications with the distributor.
  • File a complaint with the Consumer Product Safety Commission if the company is unresponsive.
  • Consider seeking legal counsel for unresolved cases involving potential consumer harm.

How to prevent similar issues

  • Buy from reputable retailers and verify CGMP compliance.
  • Check recall notices before consuming over-the-counter medications.
  • Keep packaging for recall verification and future reference.

Documentation advice

Keep the product packaging, recall notification, and any correspondence with the distributor. Take photos of the packaging and UPC/lot identifiers.

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Product Details

Three SKUs affected: 1194A (Extra Strength Assorted Berries, 12-count) with expiry 05/27; 1194C (Extra Strength Assorted Fruit, 12-count) with expiry 03/27; and Assorted 12-count product. Distribution is US nationwide. Price information unavailable.

Key Facts

  • SKU 1194A Expiry 05/27
  • SKU 1194C Expiry 03/27
  • Product: TUMS Assorted 12-count

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
1194A
1194C
Affected States
ALL
Report Date
January 21, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

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Gold Star Distribution recalled Claritin, 20 Count, on December 26, 2025, due to insanitary conditions resulting from rodent exposure. The recall affects an unknown quantity distributed nationwide. Consumers should stop using the product immediately.

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CGMP Deviations:
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