Medications & Supplements/Over-the-Counter

Unipharma, Llc.: Children's Pain, Fever, Allergy, and Cough Medications Recalled for Contamination

Agency Publication Date: May 16, 2019

Summary

Unipharma, LLC. is recalling over 202,000 units of several brands of children's liquid medications, including CVS Health and DrKids products, due to potential contamination with Burkholderia cepacia (B. cepacia) bacteria. The recall includes various children's pain and fever reducers, allergy relief, mucus relief, cough syrups, and nasal saline drops sold in single-use vials. These products were distributed nationwide in the United States and Venezuela.

Risk

The medications may be contaminated with B. cepacia bacteria, which can cause serious infections, particularly in children with weakened immune systems or underlying lung conditions. No specific injuries or illnesses have been reported for this recall, but the bacterial contamination represents a significant health risk to vulnerable users.

What You Should Do

Check your medicine cabinet for CVS Health or DrKids children's medications in single-use vials, specifically looking for those with 'Cherry', 'Mixed Berry', 'Natural Pineapple', or 'Agave' flavors.
Identify if your product is affected by matching the lot numbers and expiration dates on the packaging. Affected CVS Health lots include 80061 (Exp. 11/30/20), 80053 and 80055 (Exp. 10/31/20), 80058 and 80059 (Exp. 11/30/20), 80043 (Exp. 07/05/20), 80047 (Exp. 07/31/20), 80026 (Exp. 05/31/20), 80027 (Exp. 07/31/20), and 80054 and 80056 (Exp. 10/31/20).
Affected DrKids lots include 80058, 80060, 80061, and 80062 (Exp. 11/30/20), 80054 (Exp. 10/31/20), and Himasal lots 90002 (Exp. 01/31/21) and 90008 (Exp. 02/28/21).
Stop using any affected medication immediately to avoid the risk of bacterial infection.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any potential adverse health effects.
Return any unused vials to the place of purchase for a full refund and contact Unipharma, LLC. at their Tamarac, Florida facility for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Full refund for returned product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL (0.17 fl. oz.)

Model:

NDC 69842-0258-01

UPC Codes:

050428601891

Lot Numbers:

80061 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: CVS Health Children's Mucus Relief Chest Congestion Plus Cough (0.17 fl. oz.)

Model:

NDC 69842-260-01

UPC Codes:

050428597675

Lot Numbers:

80053 (Exp. 10/31/20)

80055 (Exp. 10/31/20)

Date Ranges: 10/31/20

Product: DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL (0.17 fl. oz.)

Model:

NDC 70302-012-20

UPC Codes:

370302255010

Lot Numbers:

80058 (Exp. 11/30/20)

80060 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL (0.17 fl. oz.)

Model:

NDC 70302-011-20

UPC Codes:

370302223019

Lot Numbers:

80061 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl (0.17 fl. oz.)

Model:

NDC 69842-261-01

UPC Codes:

050428597156

Lot Numbers:

80058 (Exp. 11/30/20)

80059 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: DrKids Children's Cough & Chest Congestion DM (0.17 fl. oz.)

Model:

NDC 70302-013-20

UPC Codes:

370302268010

Lot Numbers:

80054 (Exp. 10/31/20)

Date Ranges: 10/31/20

Product: CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief (0.08 fl. oz.)

UPC Codes:

050428597958

Lot Numbers:

80043 (Exp. 07/05/20)

80047 (Exp. 07/31/20)

Date Ranges: 07/05/20, 07/31/20

Product: DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar (0.17 fl. oz.)

UPC Codes:

370302489019

Lot Numbers:

80062 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: CVS Health Children's Nasal Saline Drops With Himalayan Salt (0.05 fl. oz.)

UPC Codes:

050428598207

Lot Numbers:

80026 (Exp. 05/31/20)

80027 (Exp. 07/31/20)

Date Ranges: 05/31/20, 07/31/20

Product: DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt (0.02 fl. oz. and 0.05 fl. oz.)

UPC Codes:

370302446081

370302446098

Lot Numbers:

90002 (Exp. 01/31/21)

90008 (Exp. 02/28/21)

Date Ranges: 01/31/21, 02/28/21

Product: CVS Health Children's Cough & Chest Congestion DM (0.17 fl. oz.)

Model:

NDC 69842-262-01

UPC Codes:

050428598368

Lot Numbers:

80054 (Exp. 10/31/20)

80056 (Exp. 10/31/20)

Date Ranges: 10/31/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82754

Status: Resolved

Manufacturer: Unipharma, Llc.

Sold By: CVS Pharmacy; CVS Health

Manufactured In: United States

Units Affected: 11 products (15264 cartons; 33360 cartons; 1060 cartons; 280 cartons; 27840 cartons; 1344 cartons; 38640 cartons; 39216 cartons; 23712 cartons; 816 cartons; 21456 cartons)

Distributed To: Nationwide

Agency Last Updated: May 23, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medicine cabinet for CVS Health or DrKids children's medications in single-use vials, specifically looking for those with 'Cherry', 'Mixed Berry', 'Natural Pineapple', or 'Agave' flavors.

Identify if your product is affected by matching the lot numbers and expiration dates on the packaging. Affected CVS Health lots include 80061 (Exp. 11/30/20), 80053 and 80055 (Exp. 10/31/20), 80058 and 80059 (Exp. 11/30/20), 80043 (Exp. 07/05/20), 80047 (Exp. 07/31/20), 80026 (Exp. 05/31/20), 80027 (Exp. 07/31/20), and 80054 and 80056 (Exp. 10/31/20).

Affected DrKids lots include 80058, 80060, 80061, and 80062 (Exp. 11/30/20), 80054 (Exp. 10/31/20), and Himasal lots 90002 (Exp. 01/31/21) and 90008 (Exp. 02/28/21).

Stop using any affected medication immediately to avoid the risk of bacterial infection.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any potential adverse health effects.

Return any unused vials to the place of purchase for a full refund and contact Unipharma, LLC. at their Tamarac, Florida facility for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL (0.17 fl. oz.)

Model:

NDC 69842-0258-01

UPC Codes:

050428601891

Lot Numbers:

80061 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: CVS Health Children's Mucus Relief Chest Congestion Plus Cough (0.17 fl. oz.)

Model:

NDC 69842-260-01

UPC Codes:

050428597675

Lot Numbers:

80053 (Exp. 10/31/20)

80055 (Exp. 10/31/20)

Date Ranges: 10/31/20

Product: DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL (0.17 fl. oz.)

Model:

NDC 70302-012-20

UPC Codes:

370302255010

Lot Numbers:

80058 (Exp. 11/30/20)

80060 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL (0.17 fl. oz.)

Model:

NDC 70302-011-20

UPC Codes:

370302223019

Lot Numbers:

80061 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl (0.17 fl. oz.)

Model:

NDC 69842-261-01

UPC Codes:

050428597156

Lot Numbers:

80058 (Exp. 11/30/20)

80059 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: DrKids Children's Cough & Chest Congestion DM (0.17 fl. oz.)

Model:

NDC 70302-013-20

UPC Codes:

370302268010

Lot Numbers:

80054 (Exp. 10/31/20)

Date Ranges: 10/31/20

Product: CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief (0.08 fl. oz.)

UPC Codes:

050428597958

Lot Numbers:

80043 (Exp. 07/05/20)

80047 (Exp. 07/31/20)

Date Ranges: 07/05/20, 07/31/20

Product: DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar (0.17 fl. oz.)

UPC Codes:

370302489019

Lot Numbers:

80062 (Exp. 11/30/20)

Date Ranges: 11/30/20

Product: CVS Health Children's Nasal Saline Drops With Himalayan Salt (0.05 fl. oz.)

UPC Codes:

050428598207

Lot Numbers:

80026 (Exp. 05/31/20)

80027 (Exp. 07/31/20)

Date Ranges: 05/31/20, 07/31/20

Product: DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt (0.02 fl. oz. and 0.05 fl. oz.)

UPC Codes:

370302446081

370302446098

Lot Numbers:

90002 (Exp. 01/31/21)

90008 (Exp. 02/28/21)

Date Ranges: 01/31/21, 02/28/21

Product: CVS Health Children's Cough & Chest Congestion DM (0.17 fl. oz.)

Model:

NDC 69842-262-01

UPC Codes:

050428598368

Lot Numbers:

80054 (Exp. 10/31/20)

80056 (Exp. 10/31/20)

Date Ranges: 10/31/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82754

Status: Resolved

Manufacturer: Unipharma, Llc.

Sold By: CVS Pharmacy; CVS Health

Manufactured In: United States

Units Affected: 11 products (15264 cartons; 33360 cartons; 1060 cartons; 280 cartons; 27840 cartons; 1344 cartons; 38640 cartons; 39216 cartons; 23712 cartons; 816 cartons; 21456 cartons)

Distributed To: Nationwide

Agency Last Updated: May 23, 2019