Lower risk Drug recall · FDA · Published November 12, 2021

Dr. Reddy's 12HR Allergy Relief Tablets: Failed Dissolution Risk

Dr. Reddy's recalls 12HR allergy relief tablets with failed dissolution specifications. Consumers should check NDC 70000-0518-1 and lot AC2103329G for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0272-2022Drug Dr. Reddy's ›

Lower-risk recall

Failed dissolution specifications

Take action

Contact the company

Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623

✎ GovInfoNow plain-language explainer

Dr. Reddy's recalls 12-hour allergy and congestion relief tablets that may not dissolve properly. This could lead to inconsistent medication delivery and potential ineffective treatment. Read more at govinfonow.com/recall/35538-dr-reddy-s-12hr-allergy-relief-tablets-failed-dissolution-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35538-dr-reddy-s-12hr-allergy-relief-tablets-failed-dissolution-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0272-2022

Cite this page

“Dr. Reddy's 12HR Allergy Relief Tablets: Failed Dissolution Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35538-dr-reddy-s-12hr-allergy-relief-tablets-failed-dissolution-risk. Based on FDA recall #D-0272-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0272-2022%22&limit=1).

The FDA announced on 2021-11-12 that Dr. Reddy's Laboratories, Inc. is recalling 12 HR Allergy & Congestion Relief Fexofenadine HCl due to failed dissolution specifications. The recall affects 2496 cartons distributed nationwide.

How to tell if you have it

Brand: Dr. Reddy's
Product: 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant
Quantity: 20 Extended-Release Tablets USP
Distributed By: Cardinal Health, Dublin, Ohio 43107
NDC: 70000-0518-1
Lot #: AC2103329G
Expiration: 1/2023
Distribution: USA Nationwide

The hazard

The product failed dissolution specifications, according to the FDA. The recall is classified as Class III.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Teva Metoprolol Succinate Tablets Recall (2026-01-29), Teva Metoprolol Succinate Extended-Release Tablets Recall (2026-01-29), and AvKARE Rosuvastatin Tablets 10mg Recall (2025-12-31).

How to tell if you have this one

Check for the NDC code 70000-0518-1 and lot number AC2103329G on the packaging. These tablets were distributed by Cardinal Health in the US and made in India.

Brand
Dr. Reddy's
Category
Drug

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
USA Nationwide.

Recall number	Product, codes & lots	Quantity	NDC
D-0267-2022	Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.; Lot #: AC2103329E, Exp 1/2023	4896 cartons	11822-7388-5
D-0268-2022	Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20; Lot #: AC2103329I, Exp 1/2023	14976 cartons	—
D-0269-2022	Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.; Lot #: AC2103329F, Exp 1/2023	5016 cartons	43598-823-14, 43598-823-31, 43598-823-35
D-0270-2022	Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.; Lot #: AC2103329H, Exp 1/2023	2352 cartons	—
D-0271-2022	Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.; Lot #: AC2103329D, Exp 1/2023	2184 cartons	—
D-0272-2022	12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.; Lot #: AC2103329G, Exp 1/2023	2496 cartons	—
D-0273-2022	Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30; Lot #: AC2103329C, Exp 1/2023	N/A	—
D-0274-2022	Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.; Lot #: AC2103329B	9,984 cartons	—
D-0275-2022	Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.; Lot #: AC2103329A	2,928 cartons	43598-823-14, 43598-823-31, 43598-823-35

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for NDC 70000-0518-1 and lot AC2103329G on the packaging to confirm if your tablets are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Nov 12, 2021Firm started the recall
Dec 7, 2021FDA classified it Class III
Dec 15, 2021Published in FDA’s Enforcement Report
Jun 23, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Dr. Reddy's recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/35538-dr-reddy-s-12hr-allergy-relief-tablets-failed-dissolution-risk">Dr. Reddy's 12HR Allergy Relief Tablets: Failed Dissolution Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0272-2022 (November 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0272-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.