HydrALAZINE Hydrochloride Tablets recall
FDA recall D-0320-2024 · initiated Feb 1, 2024
Amerisource Health Services LLC recalled HydrALAZINE Hydrochloride Tablets in Feb 2024 — an FDA Class III recall (D-0320-2024) because Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,850 cartons
Details
- Product
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 1, 2024
- FDA report date
- Feb 14, 2024
Frequently asked
- Was HydrALAZINE Hydrochloride Tablets recalled?
- Amerisource Health Services LLC recalled HydrALAZINE Hydrochloride Tablets in Feb 2024 — an FDA Class III recall (D-0320-2024) because Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was HydrALAZINE Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0320-2024 was: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
- Is a recalled HydrALAZINE Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of HydrALAZINE Hydrochloride Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 1012275, Exp 02/28/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0320-2024.