The Recall Desk
ModerateFDA (Drugs)·D-1303-2019·Announced 2019-05-22

DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

Unipharma is recalling DrKids Children's Natural Cough Syrup due to potential contamination with B. cepacia bacteria. This is a precautionary measure.

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 explicitly described as a 'precautionary measure' due to 'potential risk' of contamination, with no reported illnesses or injuries, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Unipharma, LLC is recalling 39,216 cartons of DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL). The product was manufactured in the USA and distributed nationwide and in Venezuela. The specific lot number is 80062, with an expiration date of 11/30/20.

The recall is being conducted as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. This action is related to Current Good Manufacturing Practice (CGMP) deviations.

Consumers who have purchased this product should stop using it and contact the manufacturer or return it to the place of purchase for a refund.

The recalled product

Product
DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
Manufacturer
Unipharma, Llc.
Affected units
39,216

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 (1)

  • Lot: 80062 Exp. 11/30/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Unipharma, Llc. 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 11 products in this recall →