Elevated risk U.S. Food and Drug Administration

Colgate Toothpaste recall: Product was stored outside of labeled temperature requirements

Recall published 4+ years ago

Product was stored outside of labeled temperature requirements

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Product was stored outside of labeled temperature requirements

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
September 15, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Colgate
Product type
Prescription & OTC drugs
Distribution
Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas, Utah
Sold at
Family Dollar

Products covered by this recall

Toothpaste

What the company announced

Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to a limited number of stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, and UT on or around May 1, 2022 through June 21, 2022 due to product being stored outside of labeled temperature requirements.

To date, Family Dollar is not aware of any consumer complaints or reports of illness related to this recall.

Products covered by this retail level recall include:

  • 998277: 998909 · COLGATE OPTIC WHITE STAIN PREVENTION TOOTHPASTE 2.1OZ: COLGATE OPTIC WHITE CHARCOAL TOOTHPASTE 4.2OZ
  • 998277: 999043 · COLGATE OPTIC WHITE STAIN PREVENTION TOOTHPASTE 2.1OZ: COLGATE OPTIC WHITE MOUTHWASH 16 FL OZ
  • 998277: 999088 · COLGATE OPTIC WHITE STAIN PREVENTION TOOTHPASTE 2.1OZ: COLGATE OPTIC WHITE HIGH IMPACT TOOTHPASTE 3OZ
  • 998277: 999749 · COLGATE OPTIC WHITE STAIN PREVENTION TOOTHPASTE 2.1OZ: COLGATE OPTIC WHITE TOOTHPASTE ICY FRESH 3.2OZ
  • 998277: 999750 · COLGATE OPTIC WHITE STAIN PREVENTION TOOTHPASTE 2.1OZ: COLGATE OPTIC WHITE STAIN FIGHTER TOOTHPASTE CLEAN MNT 4.2OZ

Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt.

Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

https://www.fda.gov/safety/report - problem - fda

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 2.1 OZ
  • 4.2 OZ
  • 16 FL OZ
  • 3 OZ
  • 3.2 OZ

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Colgate — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Family Dollar — Consumers: Family Dollar Customer Service, 844-636-7687

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Colgate prescription & otc drugs recalled?

Product was stored outside of labeled temperature requirements Product was stored outside of labeled temperature requirements

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Which states were affected?

The notice lists Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas, Utah.

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