Motrin Infants' Drops (McNeil) – Foreign Substance Presence (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.
Brand
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Lot Codes / Batch Numbers
Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15
Products Sold
Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. is recalling Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bott due to Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026