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.
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 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.
- Category
- Drug — Cough Syrup
- Hazard
- 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 →Related recalls
Same manufacturer · Unipharma, Llc.
See all →- SevereDrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-10-16
- ModerateCVS Children's Nasal Saline Drops Recalled for B. cepacia Contamination Risk
FDA (Drugs) · 2019-08-14
- ModerateCVS Children's Allergy Relief Liquid Medication Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-08-14
- ModerateUnipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
FDA (Drugs) · 2019-08-14
- ModerateCVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-05-22
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08
Similar recalls
- ModerateDrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-05-22
- ModerateCVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-05-22
- ModerateUnipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
FDA (Drugs) · 2019-08-14
- ModerateDrKids Children's Allergy Relief Diphenhydramine Recalled for B. cepacia Contamination Risk
FDA (Drugs) · 2019-05-22
- ModerateDrKids Children's Pain & Fever Oral Solution Recalled for B. cepacia Risk
FDA (Drugs) · 2019-05-22
- ModerateDrKids Nasal Saline Vials Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-05-22