Harvard Drug Group Fexofenadine 60mg Tablets Recall: Impurities Risk
Harvard Drug Group recalls 60mg fexofenadine tablets with impurities that could pose health risks. Affected lots expired by April 2022. Consumers should check NDC 0904-6979-40 and lot numbers.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
The Harvard Drug Group is recalling 60mg fexofenadine hydrochloride tablets that may contain impurities. This could pose health risks, so affected consumers should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/35991-harvard-drug-group-fexofenadine-60mg-tablets-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35991-harvard-drug-group-fexofenadine-60mg-tablets-recall-impurities-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0289-2022
Cite this page
“Harvard Drug Group Fexofenadine 60mg Tablets Recall: Impurities Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35991-harvard-drug-group-fexofenadine-60mg-tablets-recall-impurities-risk. Based on FDA recall #D-0289-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2022%22&limit=1).
Why it’s dangerous
The tablets may contain impurities that could cause health issues. The specific impurities are not detailed in the recall notice, so the exact risk level cannot be determined.
Who’s affected
People who purchased the 60mg fexofenadine hydrochloride tablets from The Harvard Drug Group between the specified lot dates. Those with allergies to fexofenadine or related medications are at higher risk.
How to tell if you have this one
Check for the NDC code 0904-6979-40 and lot numbers H00005 (expires Jan 2022), H00006 (expires Apr 2022), or H00007 (expires Jul 2022).
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0904-6979-40 and lot numbers H00005, H00006, or H00007 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide 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 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0289-2022 (August 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0289-2022 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.