AVKARE Fexofenadine Tablets Recall: Failed Stability Specifications
AVKARE recalls 500-tablet antihistamine bottles with failed stability specs. Products may degrade over time, causing potential safety issues. Check NDC 42291-297-50 and lot numbers for affected items.
Lower-risk recall
Failed Stability Specifications.
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What happened, in plain English
AVKARE is recalling fexofenadine hydrochloride tablets that failed stability tests. This means the medication could degrade over time, potentially affecting safety and effectiveness. Read more at govinfonow.com/recall/38068-avkare-fexofenadine-tablets-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/38068-avkare-fexofenadine-tablets-recall-failed-stability-specifications · Updated October 5, 2026 · FDA enforcement record: FDA #D-1875-2019
Cite this page
“AVKARE Fexofenadine Tablets Recall: Failed Stability Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38068-avkare-fexofenadine-tablets-recall-failed-stability-specifications. Based on FDA recall #D-1875-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1875-2019%22&limit=1).
Why it’s dangerous
The tablets failed stability specifications, meaning they may degrade over time. This could lead to reduced effectiveness or potential safety issues if the medication becomes unstable.
Who’s affected
People who own or use the recalled AVKARE Fexofenadine Hydrochloride Tablets (180 mg, 500 tablets per bottle) with specific lot numbers and expiration dates are affected. Those with the product in their possession are most at risk.
How to tell if you have this one
Check for the product name 'AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle' with NDC 42291-297-50. Affected lots are 067180011A, 067180012A (exp. 04/2021) and 06718027B1 (exp. 09/2021).
- Brand
AVKARE- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the bottle to see if it matches the recalled lots: 067180011A, 067180012A (exp. 04/2021) or 06718027B1 (exp. 09/2021).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years 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-1875-2019 (August 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1875-2019 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.