FDA-Drug2024-02-14Class III
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
Hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Sold states
Nationwide in the USA
Affected count
2,850 cartons
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2024More Amerisource Health Services LLC recalls
- FDA-Drug2026-05-27Amerisource Health Services Primidone Tablets recalled for trace Acemetacin contamination
- FDA-Drug2026-05-27Amerisource Primidone 250 mg tablets recalled for cross-contamination with Acemetacin
- FDA-Drug2026-04-01Meclizine Hydrochloride 12.5 mg tablets recalled for failed specifications
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief