DrKids Children's Cough Syrup (Unipharma) – Bacteria Risk (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
Brand
Unipharma, Llc.
Lot Codes / Batch Numbers
Lot: 80054 Exp. 10/31/20
Products Sold
Lot: 80054 Exp. 10/31/20
Unipharma, Llc. is recalling DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Be due to CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026