Mylan Fexofenadine 60mg Recall: Failed Impurity Specs
Mylan recalls Fexofenadine HCl 60mg tablets due to failed impurity specifications. Check lot #3047303, exp 04/2015.
Recall notice
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
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What happened, in plain English
Mylan Pharmaceuticals Inc. is recalling Fexofenadine HCl Tablets, USP, 60 mg because they contain out-of-specification levels of a related compound, which is a degradant of the active ingredient. The recall affects specific bottles distributed nationwide with lot number 3047303 and an expiration date of April 2015. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/44852-mylan-pharmaceuticals-inc-recalls-fexofenadine-hcl-tablets-usp-60-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/44852-mylan-pharmaceuticals-inc-recalls-fexofenadine-hcl-tablets-usp-60-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0435-2015
Cite this page
“Mylan Fexofenadine 60mg Recall: Failed Impurity Specs.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44852-mylan-pharmaceuticals-inc-recalls-fexofenadine-hcl-tablets-usp-60-mg. Based on FDA recall #D-0435-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2015%22&limit=1).
Why it’s dangerous
The recalled tablets failed specifications for a related compound, specifically a degradant of fexofenadine. The record does not describe the specific health risks or injury mechanisms associated with these impurities.
Who’s affected
Consumers who purchased prescription strength Fexofenadine HCl 60 mg tablets from Mylan Pharmaceuticals Inc. nationwide between unspecified dates prior to March 11, 2015. Individuals relying on this specific lot for allergy relief are the primary group affected.
How to tell if you have this one
Look for Fexofenadine HCl Tablets, USP, 60 mg manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV. Check for NDC codes 0378-0781-91 (60 count bottles) or 0378-0781-05 (500 count bottles). Verify the lot number is 3047303 and the expiration date is 04/2015.
- Brand
Mylan- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0435-2015 (March 11, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0435-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.