Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater
Summary
The FDA issued a Class II for Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by Ajanta Pharma USA Inc. Reason: Failed Dissolution Specifications: below specification.
Details
Source
Drug Recall
External ID
D-0010-2027
Action Date
2026-10-07
Status
Ongoing
Category
drug
Product Description
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
Lot/Code Info: Lot: DJ25134, Exp 11/30/2028
Reason for Recall
Failed Dissolution Specifications: below specification
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-17
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 23 drug recalls issued in the same week, part of 40 drug-related FDA actions this month.
Ajanta Pharma USA Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ajanta Pharma USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ajanta Pharma USA Inc have FDA actions?
Ajanta Pharma USA Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0010-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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