The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East
Major Pharmaceuticals recalls 25mg Hydralazine HCl tablets due to impurities detected during stability testing. Affected lots expire by 12/2024 and 07/2025. Consumers should check their lot numbers and contact the manufacturer for details.
Lower-risk recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Contact the company & request your remedy
What happened, in plain English
Major Pharmaceuticals is recalling 25mg Hydralazine HCl tablets that may contain impurities found during stability testing. This could pose a risk to users if the tablets degrade over time, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/32467-major-pharmaceuticals-hydralazine-tablets-recall-impurities-risk-during-storage.
Source Summary by GovInfoNow · govinfonow.com/recall/32467-major-pharmaceuticals-hydralazine-tablets-recall-impurities-risk-during-storage · Updated September 23, 2026 · FDA enforcement record: FDA #D-0045-2025
Cite this page
“Major Pharmaceuticals Hydralazine Tablets Recall: Impurities Risk During Storage.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32467-major-pharmaceuticals-hydralazine-tablets-recall-impurities-risk-during-storage. Based on FDA recall #D-0045-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0045-2025%22&limit=1).
Why it’s dangerous
The tablets may contain impurities that could change over time, potentially affecting their safety and effectiveness. This issue was detected during routine stability testing but does not indicate immediate harm to users.
Who’s affected
Prescription users of Hydralazine HCl tablets who have the affected lots (T04888, T04946, T04970) from the specified expiration dates. Patients on blood pressure medication are most at risk if the tablets degrade.
How to tell if you have this one
Check the lot number on the tablet packaging: T04888 (expires 11/2024), T04946 (expires 12/2024), or T04970 (expires 07/2025). The product is a prescription-only 25mg tablet sold in 100-count cartons.
- Brand
Major Pharmaceuticals- Category
Drug
What to do — step by step
Check Lot Number
Look for the lot numbers T04888, T04946, or T04970 on the tablet packaging.
Questions people ask
What is the specific risk of these tablets?
The tablets may contain impurities detected during stability testing, which could affect their safety and effectiveness over time.
How can I check if I have the recalled tablets?
Check the lot number on the packaging: T04888 (expires 11/2024), T04946 (expires 12/2024), or T04970 (expires 07/2025).
Do I need to stop using these tablets?
The recall does not require stopping use immediately; however, affected lots should be checked and contacted for further instructions.
Contact Major Pharmaceuticals
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0045-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0045-2025 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0045-2025 (November 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0045-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.