Perrigo Recalls Guaifenesin Liquid Due to Incorrect Dosing Cup Markings
Perrigo Company PLC is recalling specific lots of Guaifenesin liquid because the included dosing cups have incorrect dose markings.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves incorrect dosing markings, which poses a risk of medication error but is not associated with reported serious injuries or fatalities in the source text.
Plain-English summary
Perrigo Company PLC is recalling specific lots of Guaifenesin Grape liquid and Guaifenesin DM liquid. The recall is due to a defective delivery system where the dosing cups included with the product have incorrect dose markings.
The affected products are sold under various brand names, including H.E.B. Mucus Relief and CVS Children's Mucus Relief Chest Congestion. The recall covers specific lot numbers 5MK0340 and 5LK0592 with an expiration date of 08/17. The products were distributed nationwide.
Consumers should check their medication for the affected lot numbers and stop using the product if it matches the recall details. They should contact their healthcare provider or pharmacist for guidance on proper dosing or to obtain a replacement.
The recalled product
- Product
- Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made…
- Manufacturer
- Perrigo Company PLC
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 (3)
- Lot #s: 5MK0340
- 5LK0592
- Exp 08/17
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.
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