Medications & Supplements/Prescription Drugs

HydrALAZINE Hydrochloride Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: February 8, 2024

Summary

Amerisource Health Services is recalling 2,850 cartons of HydrALAZINE Hydrochloride Tablets (10 mg), a prescription medication used to treat high blood pressure. The recall was initiated after testing showed the repackaged product failed quality specifications for impurities (related compounds) at the six-month mark. This medication was distributed by American Health Packaging in 100-count unit dose cartons.

Risk

The presence of impurities or degradation products exceeding approved limits could potentially impact the long-term quality and effectiveness of the medication. No injuries or adverse events have been reported in connection with this specific quality issue.

What You Should Do

The recalled products are 100-count cartons (10 x 10 unit doses) of HydrALAZINE Hydrochloride Tablets, USP, 10 mg, distributed by American Health Packaging. Affected cartons are marked with NDC 68084-447-01, and individual unit dose labels are marked with NDC 68084-447-11.
Identify if your product is affected by checking the lot number and expiration date on the packaging. This recall specifically affects lot number 1012275 with an expiration date of 02/28/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: HydrALAZINE Hydrochloride Tablets, USP (100-count)by American Health Packaging

Variants: 10 mg, Tablet

Lot Numbers:

1012275 (Exp 02/28/2025)

NDC:

68084-447-01

68084-447-11

Recall #: D-0320-2024; Distributed by American Health Packaging in 10 x 10 unit dose cartons.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93936

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies; Hospitals; Healthcare Providers

Manufactured In: United States

Units Affected: 2,850 cartons

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products are 100-count cartons (10 x 10 unit doses) of HydrALAZINE Hydrochloride Tablets, USP, 10 mg, distributed by American Health Packaging. Affected cartons are marked with NDC 68084-447-01, and individual unit dose labels are marked with NDC 68084-447-11.

Identify if your product is affected by checking the lot number and expiration date on the packaging. This recall specifically affects lot number 1012275 with an expiration date of 02/28/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.