The Recall Desk
ModerateFDA (Drugs)·D-0587-2016·Announced 2016-02-03

Perrigo Recalls Children's Guaifenesin DM Liquid Due to Dosing Cup Errors

Perrigo is recalling specific lots of Children's Guaifenesin DM Cherry liquid because the included dosing cups have incorrect dose markings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect dosing markings on a delivery device, which fits the criteria for moderate severity involving potential harm from misuse rather than immediate severe injury.

Plain-English summary

Perrigo Company PLC is recalling specific lots of Guaifenesin DM Cherry liquid, a children's cough and cold medication. The product is sold in 4-ounce bottles under various store brands, including Sunmark, Rite-Aid, Topcare, Kroger, GoodSense, Dollar General, Care One, and CVS. The recall affects bottles with lot numbers 5LK0528, 5LK0630, and 5LK0779, which have an expiration date of 03/17.

The recall was initiated because the dosing cups included with the product have incorrect dose markings. This defect in the delivery system could lead to inaccurate dosing of the medication. The product was distributed nationwide.

Consumers should check their medication bottles for the affected lot numbers and expiration date. If the product matches the description, consumers should stop using it and return it to the place of purchase for a refund or follow instructions from the manufacturer.

The recalled product

Product
Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #s: 5LK0528
  • 5LK0630
  • 5LK0779
  • Exp 03/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Perrigo Company PLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →