The Recall Desk
ModerateFDA (Drugs)·D-0132-2020·Announced 2019-10-16

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

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

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 is explicitly described as a 'precautionary measure' due to potential contamination, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Unipharma, LLC is recalling 144 cartons of DrKids Children's Natural Cough Syrup English Ivy Leaf. The product is packaged in pre-measured single-use vials and was distributed nationwide in the United States. The specific lot affected is 80047, with an expiration date of 07/31/20.

The recall is being conducted as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations. These deviations created a potential risk of product contamination with the bacteria B. cepacia. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers who have purchased this specific lot of DrKids Children's Natural Cough Syrup should stop using the product and contact the manufacturer for instructions on how to return it or obtain a refund.

The recalled product

Product
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
Manufacturer
Unipharma, Llc.
Affected units
144

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: 80047 Exp. 07/31/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →