Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC
Mylan recalls 180mg fexofenadine tablets with slightly elevated impurities from stability testing. Consumers should check NDC codes and expiration dates for affected lots.
Lower-risk recall
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 180mg fexofenadine tablets that showed slightly elevated impurities during routine stability testing. This could pose a minor risk to consumers, but the product is not immediately dangerous. Read more at govinfonow.com/recall/39233-mylan-fexofenadine-180mg-tablets-recall-slight-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39233-mylan-fexofenadine-180mg-tablets-recall-slight-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0428-2019
Cite this page
“Mylan Fexofenadine 180mg Tablets Recall: Slight Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39233-mylan-fexofenadine-180mg-tablets-recall-slight-impurity-risk. Based on FDA recall #D-0428-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0428-2019%22&limit=1).
Why it’s dangerous
Routine stability testing found a small amount of an impurity that slightly exceeded safety limits. This impurity is not expected to cause harm but could potentially be a concern for people with specific health conditions or allergies.
Who’s affected
People who own or use the recalled 180mg fexofenadine tablets with NDC codes 0378-0782-93 or 0378-0782-05, manufactured in April 2019 lots. Those with allergies to fexofenadine or similar medications may be at higher risk.
How to tell if you have this one
Check for NDC codes 0378-0782-93 (30-count bottles) or 0378-0782-05 (500-count bottles) with expiration dates of April 2019. The product was manufactured in April 2019 lots.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC code and expiration date on the packaging to confirm if your tablets are affected.
Questions people ask
Is this product dangerous?
The recall is due to slightly elevated impurities found during routine testing, but the product is not expected to cause harm. Mylan considers this a low-risk issue.
What should I do with the recalled tablets?
The recall does not specify a remedy, so no action is required. Check the product details to confirm if your tablets are affected.
Are there any specific health conditions that make this product risky?
The recall notes a potential concern for people with allergies to fexofenadine or similar medications, but no specific health conditions are listed as high risk.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0428-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0428-2019 from Mylan. 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-0428-2019 (January 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0428-2019 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.