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Drug recall · FDA · Published June 5, 2019

Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box,

Sun Pharmaceutical recalls Allergy Relief D tablets due to potential impurities that could cause harm. Affected products include 20-count boxes with specific UPC and lot numbers. Consumers should contact CVS Pharmacy for details.

🇺🇸 FDA recall #D-1388-2019DrugSun Pharmaceutical ›
Take action

Contact the company & request your remedy

Recalling firmSun Pharmaceutical Industries, Inc.270 Prospect Plains Rd, N/A · Cranbury, NJ 08512-3605
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Pharmaceutical is recalling Allergy Relief D tablets after testing found impurities that may exceed safety limits. This could pose a risk to health, though the exact harm is not specified in the recall. Read more at govinfonow.com/recall/38724-sun-pharmaceutical-allergy-relief-d-tablets-recall-impurities-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/38724-sun-pharmaceutical-allergy-relief-d-tablets-recall-impurities-may-cause · Updated October 5, 2026 · FDA enforcement record: FDA #D-1388-2019

Cite this page

“Sun Pharmaceutical Allergy Relief D Tablets Recall: Impurities May Cause Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38724-sun-pharmaceutical-allergy-relief-d-tablets-recall-impurities-may-cause. Based on FDA recall #D-1388-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1388-2019%22&limit=1).

Why it’s dangerous

The tablets contain impurities that may exceed safety limits, potentially causing harm. However, the recall does not specify serious injury or death, indicating a low-risk scenario.

Who’s affected

People who own or use the recalled Allergy Relief D tablets, particularly those with allergies or sensitive health conditions. The risk is low but requires attention.

How to tell if you have this one

Check for the 20-count box labeled 'Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP'. Look for UPC 050428430231 and lot number GKT0791, expiring June 2020.

  • Brand
    Sun Pharmaceutical
  • Product
    Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box
  • Category
    Drug
FDA recall event · 4 products

All 4 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 II
  • Status
    Terminated
  • Distribution
    Nationwide in the USA
Recall numberProduct, codes & lotsQuantity
D-1387-2019Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0; Lot: GKT0484B, EXP 04/20209528 30 count units
D-1388-2019Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1; Lot GKT0791, EXP 06/202017,136 20-count units
D-1389-2019Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7; Lot: GKS1014, EXP 09/2019; GKT0484A, EXP 04/202014,399 30-count units
D-1390-2019Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0; Lot GKT0406, EXP 3/202017,904 20-count units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the UPC 050428430231 and lot number GKT0791 on the box.

✎ GovInfoNow

Questions people ask

What is the specific problem with these tablets?

Testing found impurities that may exceed safety limits, but the recall does not specify serious injury or death.

How can I tell if I have the recalled product?

Check for the UPC 050428430231 and lot number GKT0791 on the 20-count box.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact CVS Pharmacy for further instructions.

Take action

Contact Sun Pharmaceutical

We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.

Subject: Recall D-1388-2019 — Sun Pharmaceutical Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 6

Hello,

I own a Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box that is covered by recall D-1388-2019 from Sun Pharmaceutical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1388-2019 (June 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1388-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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