FDA Drugs recall ·
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton… recall
- Recall number
- D-0045-2025
- Date
- (initiated November 5, 2024)
- Company / brand
- Major Pharmaceuticals and Rugby Laboratories
341 Mason Rd, La Vergne, TN, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Terminated
- Units affected
- 25814 tablets
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Why was it recalled?
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Distribution
Nationwide in the US.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0045-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.