Recalls: Children’s Benadryl®, Tylenol® Cold Liquid, Rolaids® Extra Strength

Recall of Children’s BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children’s BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States.

This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil’s Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)

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Recall of Tylenol Cold Liquid Products

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, from the wholesale and retail level, three TYLENOL® Cold Multi-Symptom liquid products in order to update the labeling for these products. The specific products involved, listed below, are sold in the United States.

This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product.

McNeil Consumer Healthcare initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (< 1%) amounts of alcohol.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)

The NDC codes for the recalled products can be found on the product front panel.

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Recall of ROLAIDS® Extra Strength Softchews

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package distributed in the United States.

This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated as a precaution following consumer complaints of an uncharacteristic consistency or texture, traced to crystallized sugar in the product.

The affected product was manufactured by a third party for McNeil Consumer Healthcare, and the LOT number is 0053AG2, which can be found on the back of the ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)