Medications & Supplements/Over-the-Counter

CVS, Equate, and Other Allergy Relief Tablets Recalled for Failed Dissolution

Agency Publication Date: January 18, 2022

Summary

Dr. Reddy's Laboratories, Inc. is recalling 298,416 boxes of allergy and congestion relief tablets containing fexofenadine HCl and pseudoephedrine HCl. The recall includes various store brands such as Equate, CVS Health, Rite Aid, Kroger, and Wal-Fex D (Walgreens). The medication was recalled because it failed dissolution testing specifications, which means the tablets may not release the active ingredients as intended. There have been no reports of injuries or illnesses related to this recall to date. These products were sold at major pharmacies and retail stores across the United States.

Risk

The tablets may not dissolve properly in the body, which could cause the medication to be released too slowly or not at all. This defect may prevent the drug from effectively treating allergy and congestion symptoms as expected.

What You Should Do

This recall affects several brands of Fexofenadine HCl and Pseudoephedrine HCl extended-release tablets, including Equate (Walmart), CVS Health, Rite Aid, Kroger, Wal-Fex D (Walgreens), Leader (Cardinal Health), Rugby, and Quality Choice.
Check your product packaging for the brand name, UPC code, or NDC number to determine if your medication is part of this recall.
Identify the lot number and expiration date printed on the side or bottom of the box. See the Affected Products section below for the full list of affected codes, as more than 35 distinct lots are included.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rite Aid Pharmacy Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

UPC Codes:

011822738873

Lot Numbers:

AC2103330D (Exp. 1/31/2023)

AC2106452E (Exp. 3/31/2023)

Distributed by Rite Aid; Made in India.

Product: Kroger Allergy Relief-D, Fexofenadine HCl 60mg/Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

Lot Numbers:

AC2000968E (Exp. 8/31/2022)

AC2103328A

AC2103330I (Exp. 1/31/2023)

AC2106452B (Exp. 3/31/2023)

NDC:

30142-611-14

Distributed by the Kroger Co.; Made in India.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg (10-count)

Variants: Extended Release Tablets

UPC Codes:

343598823355

Lot Numbers:

AC2103328D (Exp. 1/31/2023)

Distributed by Dr. Reddy's Laboratories, Inc.; Made in India.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg (20-count)

Variants: Extended Release Tablets

UPC Codes:

343598823140

Lot Numbers:

AC2000968C (Exp. 8/31/2022)

Distributed by Dr. Reddy's Laboratories, Inc.; Made in India.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg (30-count)

Variants: Extended Release Tablets

UPC Codes:

343598823317

Lot Numbers:

AC2103330C (Exp. 1/31/2023)

AC2106452D (Exp. 3/31/2023)

Distributed by Dr. Reddy's Laboratories, Inc.; Made in India.

Product: Wal-Fex D (Walgreens), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

Lot Numbers:

AC2000968D (Exp. 8/31/2022)

AC2103330J (Exp. 1/31/2023)

AC2106452A

AC2106452H (Exp. 3/31/2023)

NDC:

0363-1606-20

Distributed by Walgreen Co.; Made in India.

Product: Wal-Fex D (Walgreens), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (30-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002624C (Exp. 4/30/2022)

AC2103328B

AC2103328C

AC2103330A

AC2103330B (Exp. 1/31/2023)

NDC:

0363-1606-30

Distributed by Walgreen Co.; Made in India.

Product: Rugby Antihistamine and Nasal Decongestant (30-count)

Variants: Extended Release Tablets

Lot Numbers:

AC2106452F (Exp. 3/31/2023)

NDC:

0536-1242-07

Distributed by Rugby Laboratories; Made in India.

Product: Equate Allergy Relief D (Walmart), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002624A (Exp. 4/30/2022)

AC2000968B (Exp. 8/31/2022)

AC2103328F

AC2103330E (Exp. 1/31/2023)

AC2106452I (Exp. 3/31/2023)

NDC:

49035-273-20

Distributed by Walmart Inc.; Made in India.

Product: Equate Allergy Relief D (Walmart), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (30-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002625A (Exp. 4/30/2022)

AC2103328E

AC2103330F (Exp. 1/31/2023)

AC2106452G (Exp. 3/31/2023)

NDC:

49035-273-30

Distributed by Walmart Inc.; Made in India.

Product: Quality Choice (QC) Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (10-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002624D

79C002625C (Exp. 4/30/2022)

NDC:

63868-729-10

Distributed by C.D.M.A., Inc.; Made in India.

Product: CVS Health Allergy Relief D, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

UPC Codes:

050428436189

Lot Numbers:

AC2000968A

AC2000968F (Exp. 8/31/2022)

Distributed by CVS Pharmacy Inc.; Made in India.

Product: CVS Health Allergy Relief D, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (30-count)

Variants: Extended Release Tablets

UPC Codes:

050428290538

Lot Numbers:

79C002624B (Exp. 4/30/2022)

AC2103330G

AC2103330H (Exp. 1/31/2023)

Distributed by CVS Pharmacy Inc.; Made in India.

Product: Leader (Cardinal Health) 12HR Allergy & Congestion Relief (20-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002625B (Exp. 4/30/2022)

AC2103328G (Exp. 1/31/2023)

AC2106452C (Exp. 3/31/2023)

NDC:

70000-0518-1

Distributed by Cardinal Health; Made in India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89364

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Rite Aid; Kroger; Walgreens; Rugby Laboratories; Walmart; C.D.M.A., Inc.; CVS Pharmacy; Cardinal Health

Manufactured In: India, United States

Units Affected: 9 products (67,848 boxes; 2,352 boxes; 7,080 boxes; 11,064 boxes; 9,912 boxes; 137,856 boxes; 9,984 boxes; 41,784 boxes; 10,536 boxes)

Distributed To: Nationwide

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

This recall affects several brands of Fexofenadine HCl and Pseudoephedrine HCl extended-release tablets, including Equate (Walmart), CVS Health, Rite Aid, Kroger, Wal-Fex D (Walgreens), Leader (Cardinal Health), Rugby, and Quality Choice.

Check your product packaging for the brand name, UPC code, or NDC number to determine if your medication is part of this recall.

Identify the lot number and expiration date printed on the side or bottom of the box. See the Affected Products section below for the full list of affected codes, as more than 35 distinct lots are included.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rite Aid Pharmacy Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

UPC Codes:

011822738873

Lot Numbers:

AC2103330D (Exp. 1/31/2023)

AC2106452E (Exp. 3/31/2023)

Distributed by Rite Aid; Made in India.

Product: Kroger Allergy Relief-D, Fexofenadine HCl 60mg/Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

Lot Numbers:

AC2000968E (Exp. 8/31/2022)

AC2103328A

AC2103330I (Exp. 1/31/2023)

AC2106452B (Exp. 3/31/2023)

NDC:

30142-611-14

Distributed by the Kroger Co.; Made in India.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg (10-count)

Variants: Extended Release Tablets

UPC Codes:

343598823355

Lot Numbers:

AC2103328D (Exp. 1/31/2023)

Distributed by Dr. Reddy's Laboratories, Inc.; Made in India.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg (20-count)

Variants: Extended Release Tablets

UPC Codes:

343598823140

Lot Numbers:

AC2000968C (Exp. 8/31/2022)

Distributed by Dr. Reddy's Laboratories, Inc.; Made in India.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg (30-count)

Variants: Extended Release Tablets

UPC Codes:

343598823317

Lot Numbers:

AC2103330C (Exp. 1/31/2023)

AC2106452D (Exp. 3/31/2023)

Distributed by Dr. Reddy's Laboratories, Inc.; Made in India.

Product: Wal-Fex D (Walgreens), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

Lot Numbers:

AC2000968D (Exp. 8/31/2022)

AC2103330J (Exp. 1/31/2023)

AC2106452A

AC2106452H (Exp. 3/31/2023)

NDC:

0363-1606-20

Distributed by Walgreen Co.; Made in India.

Product: Wal-Fex D (Walgreens), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (30-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002624C (Exp. 4/30/2022)

AC2103328B

AC2103328C

AC2103330A

AC2103330B (Exp. 1/31/2023)

NDC:

0363-1606-30

Distributed by Walgreen Co.; Made in India.

Product: Rugby Antihistamine and Nasal Decongestant (30-count)

Variants: Extended Release Tablets

Lot Numbers:

AC2106452F (Exp. 3/31/2023)

NDC:

0536-1242-07

Distributed by Rugby Laboratories; Made in India.

Product: Equate Allergy Relief D (Walmart), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002624A (Exp. 4/30/2022)

AC2000968B (Exp. 8/31/2022)

AC2103328F

AC2103330E (Exp. 1/31/2023)

AC2106452I (Exp. 3/31/2023)

NDC:

49035-273-20

Distributed by Walmart Inc.; Made in India.

Product: Equate Allergy Relief D (Walmart), Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (30-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002625A (Exp. 4/30/2022)

AC2103328E

AC2103330F (Exp. 1/31/2023)

AC2106452G (Exp. 3/31/2023)

NDC:

49035-273-30

Distributed by Walmart Inc.; Made in India.

Product: Quality Choice (QC) Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (10-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002624D

79C002625C (Exp. 4/30/2022)

NDC:

63868-729-10

Distributed by C.D.M.A., Inc.; Made in India.

Product: CVS Health Allergy Relief D, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (20-count)

Variants: Extended Release Tablets

UPC Codes:

050428436189

Lot Numbers:

AC2000968A

AC2000968F (Exp. 8/31/2022)

Distributed by CVS Pharmacy Inc.; Made in India.

Product: CVS Health Allergy Relief D, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg (30-count)

Variants: Extended Release Tablets

UPC Codes:

050428290538

Lot Numbers:

79C002624B (Exp. 4/30/2022)

AC2103330G

AC2103330H (Exp. 1/31/2023)

Distributed by CVS Pharmacy Inc.; Made in India.

Product: Leader (Cardinal Health) 12HR Allergy & Congestion Relief (20-count)

Variants: Extended Release Tablets

Lot Numbers:

79C002625B (Exp. 4/30/2022)

AC2103328G (Exp. 1/31/2023)

AC2106452C (Exp. 3/31/2023)

NDC:

70000-0518-1

Distributed by Cardinal Health; Made in India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89364

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Rite Aid; Kroger; Walgreens; Rugby Laboratories; Walmart; C.D.M.A., Inc.; CVS Pharmacy; Cardinal Health

Manufactured In: India, United States

Units Affected: 9 products (67,848 boxes; 2,352 boxes; 7,080 boxes; 11,064 boxes; 9,912 boxes; 137,856 boxes; 9,984 boxes; 41,784 boxes; 10,536 boxes)

Distributed To: Nationwide