Ajanta Pharma USA Inc: Ranolazine Extended-release Tablets, 1000 Mg, 60-count Bottle
Recall Summary Ajanta Pharma USA Inc. is recalling Ranolazine Extended-Release Tablets (1000 mg, 60-count bottles) because the medication did not dissolve properly in the body as specified. The affected product was distributed nationwide across all U.S. states and Washington D.C. This is a Class II recall, meaning the product could result in serious adverse health consequences or death.
- Recalling firm
- Ajanta Pharma USA Inc
- Product
- Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
- Reason
- Failed Dissolution Specifications: below specification
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-17
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the US.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/118d4bb7-b59d-40a6-9eb0-c405b311831d