FDA Drug Recalls

Recalls / Class II

Class IID-1368-2022

Product

Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring Mint Antiseptic Mouth Rinse 8.5 OZ SKU 900273 Swan Original Antiseptic Mouth Rinse 8.5 OZ SKU 900938 Colgate Optic White Mouthwash 16 FL OZ SKU 999043 Crest Scope Classic Original Min Mouthwash 1 Ltr SKU 908109 Listerine Cool Mint Mouthwash 500 mL SKU 908223 Act Kids Bubble Gum Blowout Mouthwash 16.9 Fl OZ SKU 999935 Swan Ice Mint Antiseptic Mouth Rinse 8.5 OZ SKU 903150 Swan Mouthwash Cool Mint 1 Liter SKU 908466 Crest Mouthwash Pro Health Multi Protection Mint 1 Liter SKU 908123, Colgate Mouthwash Total Advanced Peppermint Blast 1 Liter SKU 903156 Listerine Total Care Freshmine 1 Liter SKU 900980 Listerine Ultra Clean Cool Mint 1 Liter SKU 901904 Listerine Mouthwash Freshburst 1 Liter SKU 903159 Listerine Mouthwas Original Amber 1 Liter SKU 908004 Listerine Mouthwash Coolmint 1 Liter SKU 908005 Swan Antiseptic Rinse Amber 1 Liter SKU 908465 Crest Scope Mouthwash All Day 1 Liter SKU 998269 Listerine Mouthwash Coolmint 95 Milliliters SKU 999752 Swan Fresh Mint Mouthwash 1 Liter SKU 999762 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Affected lot / code info
SKUs: 900733; 902704; 908114; 998273; 999050; 900273; 900938; 999043; 908109; 908223; 999935; 903150; 908466; 908123; 903156; 900980; 901904; 903159; 908004; 908005; 908465; 998269; 999752; 999762

Why it was recalled

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recalling firm

Firm
Family Dollar Stores, Llc.
Notification channel
Other
Type
Voluntary: Firm initiated
Address
500 Volvo Pkwy, Chesapeake, Virginia 23320-1604

Distribution

Quantity
Unknown.
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2022-06-23
FDA classified
2022-08-22
Posted by FDA
2022-08-31
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1368-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.