The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0653-2022·Announced 2022-03-23

hydrALAZINE HCl Tablets 10 mg Recalled for Failed Impurity Specifications

The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg due to failed impurity and degradation specifications detected during routine stability testing. The recall affects 5,953 cartons distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving failed stability specifications detected during routine testing. No illnesses, injuries, or adverse events are reported in the source text. The hazard is identified through quality control testing rather than real-world harm, making this a precautionary recall that meets the Moderate severity threshold for Class II recalls without reported adverse outcomes.

Plain-English summary

The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg (NDC # 0904-6440-61) distributed by MAJOR PHARMACEUTICALS. The recall involves 5,953 cartons containing 100 tablets per carton in 10x10 blister pack configurations.

The recall was initiated due to out-of-specification results obtained during routine stability testing for impurities and degradation. This indicates that the product did not meet established quality standards for chemical purity and stability.

The affected lots are T03755 and T03756 with an expiration date of 03/2023. The product was distributed nationwide within the USA as a prescription medication.

Patients currently taking this medication should consult their healthcare provider or pharmacist immediately regarding this recall.

The recalled product

Product
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Manufacturer
The Harvard Drug Group
Category
Drug — Cardiovascular / Antihypertensive
Hazard
Affected units
5,953

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: T03755
  • T03756
  • Exp. Date 03/2023

Distribution

Distributed nationwide across the United States.

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