Is TYLENOL¿ COLD HEAD CONGESTION SEVERE Daytime Cool Burst¿ CAPLETS - UPC's 300450261021 (2 count), 300450261243 (24 count), 300450261229 (48 count club code), 300450261502 (2 count) recalled?

Low RiskFDA Drug

Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.: CGMP Deviations: Review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented.; CGMP Deviations: Review of past production record found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented.; Review of past production record found instances where equipment cleaning procedures were insufficient or th

Agency Publication Date: September 30, 2011

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 57680

Status: Resolved

Manufacturer: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.

Manufactured In: United States

Units Affected: 27 products (1,122,487 bottles; 1,487,792 bottles; 1,479,792 bottles; 1,670,688 bottles; 1,552,832 bottles; 1,006,848 bottles; 971,555 bottles; 1,722,768 bottles; 543,216 bottles; 367,872 bottles; 979,776 bottles; 52,176 bottles; 174,672 bottles; 3,240,912 bottles; 6,870,299 bottles; 576,576 blister pack; 1,390,416 bottles; 1,313,088 bottles; 3,026,376 bottles; 708,432 bottles; 1,528,084; 655,704 bottles; 3,021,000 bottles; 435,816 bottles; 4,132,968 botttles; 1,405,260 bottles; 220,008 bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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