Amerisource Health Services LLC recalls HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by:
Amerisource Health Services recalls HydrALAZINE Hydrochloride Tablets due to impurities detected at 6 months. This may affect safety for patients using prescription medication. Check NDC codes 68084-447-01 or 68084-447-11 for affected units.
Recall notice
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Contact the company & request your remedy
What happened, in plain English
Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) because impurities were found in the product after 6 months. This could pose a safety risk for patients using the medication as prescribed. Read more at govinfonow.com/recall/32842-hydralazine-tablets-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/32842-hydralazine-tablets-recall-impurities-may-cause-harm · Updated September 23, 2026 · FDA enforcement record: FDA #D-0320-2024
Cite this page
“HydrALAZINE Tablets Recall: Impurities May Cause Harm.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32842-hydralazine-tablets-recall-impurities-may-cause-harm. Based on FDA recall #D-0320-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0320-2024%22&limit=1).
Why it’s dangerous
The product failed impurities and degradation tests at the 6-month mark. This means the medication may contain harmful substances that could affect patient safety when taken as directed.
Who’s affected
Patients prescribed HydrALAZINE Hydrochloride Tablets by a healthcare provider. Those using the specific NDC codes 68084-447-01 or 68084-447-11 are most at risk.
How to tell if you have this one
Check for NDC carton code 68084-447-01 or unit dose code 68084-447-11. The product was distributed by American Health Packaging in Columbus, Ohio, with lot number 1012275 expiring February 28, 2025.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC codes 68084-447-01 or 68084-447-11 to confirm if your tablets are affected.
Questions people ask
Is this product safe to use?
The recall indicates impurities were found at 6 months, but the official notice does not specify if the product is safe to use after this period.
How can I check if my tablets are affected?
Look for NDC carton code 68084-447-01 or unit dose code 68084-447-11 on the packaging.
What should I do if I have the recalled product?
The recall notice does not provide specific action steps for affected products.
Contact Amerisource Health Services
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0320-2024 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0320-2024 from Amerisource Health Services. 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-0320-2024 (February 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0320-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.