openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 6
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviation
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Code information
SKUs 998277 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Distribution pattern
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
drug · product 2 of 6
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviation
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Code information
SKUs 999088 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Distribution pattern
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
drug · product 3 of 6
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviation
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Code information
SKUs 999749 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Distribution pattern
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
drug · product 4 of 6
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviation
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Code information
SKUs 998909 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Distribution pattern
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
drug · product 5 of 6
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviation
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Code information
SKUs 999750 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Distribution pattern
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
drug · product 6 of 6
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.
