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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Allergy & Congestion Relief Tablets Recalled for Failed Dissolution

Agency Publication Date: December 7, 2021
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Summary

Dr. Reddy's Laboratories, Inc. has recalled approximately 44,832 cartons of various store-brand Allergy & Congestion Relief tablets containing the active ingredients fexofenadine HCl (60 mg) and pseudoephedrine HCl (120 mg). The recalled products were sold under labels for Rite Aid, CVS Pharmacy, Rugby Laboratories, Cardinal Health, and Walmart. The recall was initiated because the extended-release tablets failed dissolution testing, meaning they may not dissolve at the correct rate to deliver the medication effectively.

Risk

If the tablets do not dissolve correctly, the medication may not be released as intended, which can reduce its effectiveness in relieving allergy and congestion symptoms. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall involves multiple brands of 12-hour Allergy & Congestion Extended-Release Tablets (Fexofenadine HCl 60 mg/Pseudoephedrine HCl 120 mg) including versions sold at Rite Aid, CVS Pharmacy, Rugby Laboratories, Cardinal Health, and Walmart.
  2. Check the medication packaging for lot numbers AC2103329A, AC2103329B, AC2103329C, AC2103329D, AC2103329E, AC2103329F, AC2103329G, AC2103329H, or AC2103329I. See the Affected Products section below for the full list of affected codes.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP (20 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329E (Exp 1/2023)
NDC:
11822-7388-5

Distributed by Rite Aid

Product: CVS Pharmacy Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets (20 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329I (Exp 1/2023)
NDC:
69842-249-20

Distributed by CVS Pharmacy, Inc.

Product: Dr. Reddy's Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion (20 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329F (Exp 1/2023)
NDC:
43598-823-14

Distributed by Dr. Reddy's Laboratories, Inc.

Product: Rugby Antihistamine & Nasal Decongestant Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets USP (20 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg, 12 Hour
Lot Numbers:
AC2103329H (Exp 1/2023)
NDC:
0536-1242-34

Distributed by Rugby Laboratories

Product: Rugby Antihistamine & Nasal Decongestant Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets USP (30 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg, 12 Hour
Lot Numbers:
AC2103329D (Exp 1/2023)
NDC:
0638-1242-07

Distributed by Rugby Laboratories

Product: Cardinal Health 12 HR Allergy & Congestion Relief Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg (20 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329G (Exp 1/2023)
NDC:
70000-0518-1

Distributed by Cardinal Health

Product: CVS Pharmacy Allergy Relief D Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg (30 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329C (Exp 1/2023)
NDC:
69842-249-30

Distributed by CVS Pharmacy Inc.

Product: Walmart Allergy Relief D Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg (30 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329B
NDC:
49035-273-30

Distributed by Walmart Inc.

Product: Dr. Reddy's Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy and Congestion (30 Tablets)
Variants: Extended-Release Tablets, 60 mg / 120 mg
Lot Numbers:
AC2103329A
NDC:
43598-823-31

Distributed by Walmart Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89042
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Rite Aid; CVS Pharmacy; Rugby Laboratories; Cardinal Health; Walmart
Manufactured In: United States, India
Units Affected: 8 products (4896 cartons; 14976 cartons; 5016 cartons; 2352 cartons; 2184 cartons; 2496 cartons; 9,984 cartons; 2,928 cartons)
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 ยท 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.