Unipharma DrKids Children's Cough & Chest Congestion DM Recall

Why it was recalled

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Product description

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

Lot numbers, UPCs & expiration codes

Lot: 80054 Exp. 10/31/20

Where it was sold

Nationwide and Venezuela

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1301-2019
Classification: Class II
Status: Terminated
Recall initiated: May 2, 2019
FDA report date: May 22, 2019
Quantity: 1344 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: Unipharma, Llc.

Original FDA data

Every field from FDA enforcement report D-1301-2019, exactly as published.

Show all FDA fields

City: Tamarac
State: FL
Status: Terminated
Country: United States
Event ID: 82754
Address: 10200 NW 67th St
Code information: Lot: 80054 Exp. 10/31/20
Postal code: 33321-6404
Report date: May 22, 2019
Product type: Drugs
Recall number: D-1301-2019
Classification: Class II
Recalling firm: Unipharma, Llc.
Product quantity: 1344 cartons
Termination date: Nov 25, 2020
Reason for recall: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide and Venezuela
Recall initiation date: May 2, 2019
Initial firm notification: Letter
Center classification date: May 23, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1301-2019, published May 22, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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