Colgate Total SF Toothpaste recalled for improper storage temperature exposure
Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a CGMP deviation regarding storage temperature exposure with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing process compliance issue rather than demonstrated product harm, consistent with a precautionary recall.
Plain-English summary
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint flavor, distributed by COLGATE-PALMOLIVE CO. is being recalled. Batch 1293US561C is affected.
The recall was initiated due to CGMP deviations in manufacturing and handling. Products in this batch were exposed to temperatures outside of the temperatures stated on the product label for storage. This deviation from proper storage conditions could impact product quality and efficacy.
The affected product was distributed nationwide in the United States.
Consumers who have purchased this product should discontinue use and contact the manufacturer or consult a healthcare provider if they have questions.
The recalled product
- Product
- Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Toothpaste
- Hazard
- improper-storage
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch 1293US561C
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27