Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported February 21, 2024
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards),… - a moderate-severity action.
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards),… was recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories in February 21, 2024. Reason: an out of specification result obtained during routine stability testing for Impurities. There is a remote p…. Check the official notice for the remedy. Verify recall #D-0324-2024 with the FDA Drug before acting.
The recall
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories issued this moderate-severity FDA Drug recall-an out of specification result obtained during routine stability testing for Impurities. There is a remote p….
- Moderate
- severity level
- 8K units
- affected scope
- Class II
- classification
- February 21, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0324-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0324-2024) was formally reported on February 21, 2024, with the manufacturer initiating the action on February 9, 2024. It is classified under Moderate severity (Class II), with a current status of Terminated. The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories is listed as the recalling firm, operating out of La Vergne, TN. Federal records list the affected scope as 8,198 units.
The documented reason for this recall is: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequence… Distribution data in the federal record shows the product reached: The product was distributed nationwide within the United States.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,198 units
Related Recalls
6
5 from same agency
Product description
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Reason for recall
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0324-2024 |
| Date reported | February 21, 2024 |
| Date initiated | February 9, 2024 |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
| Firm location | La Vergne, TN |
| Affected scope | 8,198 units |
| Distribution | The product was distributed nationwide within the United States. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0324-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 8,198 units.
Why was this product recalled? ▼
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2024. Severity: Moderate. Recall number: D-0324-2024.
Where was the recalled product distributed? ▼
Distribution: The product was distributed nationwide within the United States..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0324-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 21, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.