HydrALAZINE Tablets Recall: Impurities Risk After 12 Months
Amerisource Health Services recalls HydrALAZINE Hydrochloride Tablets due to impurities detected at 12 months. This may affect safety if stored too long. Check your carton for NDC 68084-447-01.
Lower-risk recall
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Contact the company
What happened, in plain English
Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets because impurities were found in repackaged products after 12 months. This could pose a safety risk if the tablets are stored longer than the expiration date. Read more at govinfonow.com/recall/33143-hydralazine-tablets-recall-impurities-risk-after-12-months.
Source Summary by GovInfoNow · govinfonow.com/recall/33143-hydralazine-tablets-recall-impurities-risk-after-12-months · Updated August 17, 2026 · FDA enforcement record: FDA #D-0039-2024
Cite this page
“HydrALAZINE Tablets Recall: Impurities Risk After 12 Months.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33143-hydralazine-tablets-recall-impurities-risk-after-12-months. Based on FDA recall #D-0039-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0039-2024%22&limit=1).
Why it’s dangerous
The tablets were repackaged and tested at 12 months, but impurities were found. This could lead to potential safety issues if the product is used after the expiration date.
Who’s affected
Prescription patients who received HydrALAZINE Hydrochloride Tablets with NDC 68084-447-01. Those who have the tablets past their expiration date (Dec 31, 2023) are most at risk.
How to tell if you have this one
Look for cartons labeled NDC 68084-447-01 with lot number 1007002, expiring Dec 31, 2023. The product is prescription-only and sold through American Health Packaging.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Expiration Date
Verify the expiration date on the carton; if it's after December 31, 2023, do not use the tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the 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 10 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-0039-2024 (September 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0039-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.