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Lower risk Drug recall · FDA · Published January 4, 2022

Dr. Reddy's QC QUALITY CHOICE allergy tablets recalled for failed dissolution specs

Dr. Reddy's QC QUALITY CHOICE extended-release allergy tablets with failed dissolution specifications are recalled. Consumers should check NDC 63868-729-10 and lot numbers 79C002624D/79C002625C.

🇺🇸 FDA recall #D-0384-2022DrugDr. Reddy's ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
✎ GovInfoNow plain-language explainer

What happened, in plain English

Dr. Reddy's QC QUALITY CHOICE allergy tablets (60mg fexofenadine and 120mg pseudoephedrine) are being recalled because they failed dissolution specifications. This means the medication may not work as intended, potentially leading to ineffective treatment. Read more at govinfonow.com/recall/35399-dr-reddy-s-qc-quality-choice-allergy-tablets-recalled-for.

Source Summary by GovInfoNow · govinfonow.com/recall/35399-dr-reddy-s-qc-quality-choice-allergy-tablets-recalled-for · Updated August 18, 2026 · FDA enforcement record: FDA #D-0384-2022

Cite this page

“Dr. Reddy's QC QUALITY CHOICE allergy tablets recalled for failed dissolution specs.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35399-dr-reddy-s-qc-quality-choice-allergy-tablets-recalled-for. Based on FDA recall #D-0384-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0384-2022%22&limit=1).

Why it’s dangerous

The tablets failed dissolution specifications, meaning they may not release the medication properly in the body. This could result in the medication not working as intended, leading to ineffective allergy treatment.

Who’s affected

People who own or use QC QUALITY CHOICE allergy tablets with NDC 63868-729-10 and lot numbers 79C002624D or 79C002625C (expired 4/30/2022) are affected. Those with allergies to fexofenadine or pseudoephedrine should avoid these products.

How to tell if you have this one

Check the product label for NDC 63868-729-10 and lot numbers 79C002624D or 79C002625C. The expiration date is 4/30/2022.

  • 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
    Nationwide in the USA
Recall numberProduct, codes & lotsQuantityNDC
D-0378-2022Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.; Lot #s: a) (20-count box): AC2000968D, Exp. 8/31/2022; AC2103330J, Exp. 1/31/2023; AC2106452A; AC2106452H, Exp. 3/31/2023. b) (30-count box): 79C002624C, Exp. 4/30/2022; AC2103328B; AC2103328C; AC2103330A; AC2103330B, Exp. 1/31/2023.67,848 boxes0363-1606-30, 0363-1606-20
D-0379-2022Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.; Lot #: AC2106452F, Exp. 3/31/20232,352 boxes—
D-0380-2022Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.; Lot #: AC2103330D, Exp.1/31/2023; AC2106452E, Exp. 3/31/2023.7,080 boxes—
D-0381-2022Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.; Lot #s: AC2000968E, Exp. 8/31/2022; AC2103328A; AC2103330I, Exp. 1/31/2023; AC2106452B, Exp. 3/31/2023.11,064 boxes30142-611-14
D-0382-2022Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.; Lot #s: a) (10-count): AC2103328D, Exp. 1/31/2023. b) (20-count) :AC2000968C, Exp. 8/31/2022. c) (30-count): AC2103330C, Exp. 1/31/2023; AC2106452D, Exp. 3/31/2023.9,912 boxes—
D-0383-2022equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.; Lot #s: a) (20-count): 79C002624A, Exp. 4/30/2022; AC2000968B, Exp. 8/31/2022; AC2103328F; AC2103330E, Exp.1/31/2023; AC2106452I, Exp. 3/31/2023. b) (30-count): 79C002625A, Exp. 4/30/2022; AC2103328E; AC2103330F, Exp. 1/31/2023; AC2106452G, Exp. 3/31/2023.137,856 boxes—
D-0384-2022QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.; Lot #s: 79C002624D; 79C002625C, Exp. 4/30/2022.9,984 boxes—
D-0385-2022CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.; Lot #s: a) (20-count): AC2000968A; AC2000968F, Exp. 8/31/2022. b) (30-count): 79C002624B, Exp. 4/30/2022; AC2103330G; AC2103330H, Exp. 1/31/2023.41,784 boxes—
D-0386-2022Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.; Lot #s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023.10,536 boxes—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for NDC 63868-729-10 and lot numbers 79C002624D or 79C002625C on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jan 4, 202212. FDA classified it Class III: Jan 18, 202223. Published in FDA’s Enforcement Report: Jan 26, 202234. FDA terminated the recall: Oct 20, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury from this product?

The recall is for ineffective treatment, not a risk of serious injury. This is a low-risk issue.

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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-0384-2022 (January 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0384-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA