FDA Drug Recalls

Recalls / Class II

Class IID-0174-2024

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

Affected lot / code info
Batch 1293US561C

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Recalling firm

Firm
CARDINAL HEALTHCARE
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7200 Cardinal Pl W, Dublin, Ohio 43017-1094

Distribution

Quantity
1 unit
Distribution pattern
Nationwide USA

Timeline

Recall initiated
2022-01-26
FDA classified
2023-12-26
Posted by FDA
2024-01-03
Terminated
2024-09-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0174-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls