Sun Pharmaceutical Fexofenadine 180mg Tablets Recall: Impurities Risk Safety
Sun Pharmaceutical recalls 180mg fexofenadine tablets due to failed impurities and degradation specifications. Affected lots expire by March 2027 or October 2026. Consumers should check NDC codes and lot numbers.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling 180mg fexofenadine hydrochloride tablets that may have impurities or degradation issues. This could pose a safety risk to consumers using the medication. Read more at govinfonow.com/recall/31247-sun-pharmaceutical-fexofenadine-180mg-tablets-recall-impurities-risk-safety.
Source Summary by GovInfoNow · govinfonow.com/recall/31247-sun-pharmaceutical-fexofenadine-180mg-tablets-recall-impurities-risk-safety · Updated August 10, 2026 · FDA enforcement record: FDA #D-0654-2026
Cite this page
“Sun Pharmaceutical Fexofenadine 180mg Tablets Recall: Impurities Risk Safety.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31247-sun-pharmaceutical-fexofenadine-180mg-tablets-recall-impurities-risk-safety. Based on FDA recall #D-0654-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0654-2026%22&limit=1).
Why it’s dangerous
The tablets may contain impurities or degrade in a way that could affect safety. This failure in quality control could lead to potential health risks if the medication is taken as intended.
Who’s affected
People who own or use the recalled fexofenadine tablets, particularly those with the specific lot numbers and expiration dates listed in the recall notice.
How to tell if you have this one
Check the NDC code 66336-561-30 on the product label. Look for lot numbers DNG0283A (expiring 03/31/2027) or DNF0922A/DNF0923B (expiring 10/31/2026).
- Brand
Sun Pharmaceutical Industries- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 66336-561-30 and lot numbers DNG0283A, DNF0922A, or DNF0923B on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the specific product being recalled?
Fexofenadine Hydrochloride Tablets, USP 180 mg, 150 tablets per bottle, distributed by Ohm Laboratories.
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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-0654-2026 (June 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0654-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.