Medications & Supplements/Over-the-Counter

Sun Pharmaceutical Industries, Inc.: Fexofenadine and Pseudoephedrine Tablets Recalled for Impurity Specifications

Agency Publication Date: June 14, 2019

Summary

Sun Pharmaceutical Industries, Inc. is recalling approximately 58,967 units of Allergy Relief D and Wal-Fex D (fexofenadine HCl and pseudoephedrine HCl) extended-release tablets. These allergy and congestion medications were found to have elevated levels of impurities or degradation substances that were at or above the allowed safety specification limits during testing. The affected products include 20-count and 30-count boxes sold at CVS Pharmacy and Walgreens nationwide.

Risk

The presence of impurities or degradation products above the established safety limits can potentially lead to reduced effectiveness of the medication or expose consumers to unintended chemical substances that have not been qualified for safety at these higher levels.

What You Should Do

Check your medication packaging to see if you have Allergy Relief D or Wal-Fex D (Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg) Extended-Release Tablets.
For CVS Allergy Relief D (30-count, UPC 0 50428 39131 0), check for lot GKT0484B with expiration date 04/2020.
For CVS Allergy Relief D (20-count, UPC 0 50428 43023 1), check for lot GKT0791 with expiration date 06/2020.
For Walgreens Wal-Fex D (30-count, UPC 3 11917 19454 7), check for lots GKS1014 (Exp 09/2019) or GKT0484A (Exp 04/2020).
For Walgreens Wal-Fex D (20-count, UPC 3 11917 19453 0), check for lot GKT0406 with expiration date 3/2020.
Contact your healthcare provider or pharmacist for guidance regarding your allergy treatment and return any unused medication to the pharmacy for a refund.
Contact Sun Pharmaceutical Industries, Inc. at their New Jersey distributor office for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug Recall Baseline Remedy

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

Affected Products

Product: Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets (30-count box)

Model:

D-1387-2019

UPC Codes:

050428391310

Lot Numbers:

GKT0484B (Exp 04/2020)

Date Ranges: EXP 04/2020

Product: Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets (20-count box)

Model:

D-1388-2019

UPC Codes:

050428430231

Lot Numbers:

GKT0791 (Exp 06/2020)

Date Ranges: EXP 06/2020

Product: Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, Allergy & Congestion (30-count box)

Model:

D-1389-2019

UPC Codes:

311917194547

Lot Numbers:

GKS1014 (Exp 09/2019)

GKT0484A (Exp 04/2020)

Date Ranges: EXP 09/2019, EXP 04/2020

Product: Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, Allergy & Congestion (20-count box)

Model:

D-1390-2019

UPC Codes:

311917194530

Lot Numbers:

GKT0406 (Exp 3/2020)

Date Ranges: EXP 3/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83025

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: CVS Pharmacy; Walgreens

Manufactured In: India, United States

Units Affected: 4 products (9528 30 count units; 17,136 20-count units; 14,399 30-count units; 17,904 20-count units)

Distributed To: Nationwide

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

What You Should Do

Check your medication packaging to see if you have Allergy Relief D or Wal-Fex D (Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg) Extended-Release Tablets.

For CVS Allergy Relief D (30-count, UPC 0 50428 39131 0), check for lot GKT0484B with expiration date 04/2020.

For CVS Allergy Relief D (20-count, UPC 0 50428 43023 1), check for lot GKT0791 with expiration date 06/2020.

For Walgreens Wal-Fex D (30-count, UPC 3 11917 19454 7), check for lots GKS1014 (Exp 09/2019) or GKT0484A (Exp 04/2020).

For Walgreens Wal-Fex D (20-count, UPC 3 11917 19453 0), check for lot GKT0406 with expiration date 3/2020.

Contact your healthcare provider or pharmacist for guidance regarding your allergy treatment and return any unused medication to the pharmacy for a refund.

Contact Sun Pharmaceutical Industries, Inc. at their New Jersey distributor office for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets (30-count box)

Model:

D-1387-2019

UPC Codes:

050428391310

Lot Numbers:

GKT0484B (Exp 04/2020)

Date Ranges: EXP 04/2020

Product: Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets (20-count box)

Model:

D-1388-2019

UPC Codes:

050428430231

Lot Numbers:

GKT0791 (Exp 06/2020)

Date Ranges: EXP 06/2020

Product: Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, Allergy & Congestion (30-count box)

Model:

D-1389-2019

UPC Codes:

311917194547

Lot Numbers:

GKS1014 (Exp 09/2019)

GKT0484A (Exp 04/2020)

Date Ranges: EXP 09/2019, EXP 04/2020

Product: Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, Allergy & Congestion (20-count box)

Model:

D-1390-2019

UPC Codes:

311917194530

Lot Numbers:

GKT0406 (Exp 3/2020)

Date Ranges: EXP 3/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83025

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: CVS Pharmacy; Walgreens

Manufactured In: India, United States

Units Affected: 4 products (9528 30 count units; 17,136 20-count units; 14,399 30-count units; 17,904 20-count units)

Distributed To: Nationwide