The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2024-11-20 Health moderate FDA
Health · FDA · Recall #FDA-D-0045-2025
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet… Recall
Issued November 20, 2024 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In November 2024, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
What you should do
- 1 Stop using Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Health
- Recall date
- November 20, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the US.
- Recall number
- FDA-D-0045-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 12 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.