Amerisource Health Services LLC HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose Recall 2024
Amerisource Health Services LLCIssued February 1, 2024
Amerisource Health Services LLC 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 — recalled per FDA on 2/1/2024. Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point..
What to do right now
- 1
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
- 2
Verify the match
Compare lot numbers, UPCs, and dates against your product.
- 3
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
Verified source
U.S. Food and Drug Administration
Summary of the official FDA notice issued February 1, 2024. Last synced Apr 27, 2026. View on fda.gov
What's recalled
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
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.
Affected products & lot numbers2 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot #: 1012275 |
| Exp 02/28/2025 |
Where was it sold1 state
Nationwide in the USA
View all questions for this recall →
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Frequently asked questions
Is the Amerisource Health Services LLC recall still active?
Yes, this recall is currently active as of February 1, 2024. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot #: 1012275, Exp 02/28/2025. Check the label on your product.
What should I do if I have the recalled Amerisource Health Services LLC?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.