Class IIDrug
Ranolazine Extended-Release Tablets recall
Summary
Ajanta Pharma USA Inc is recalling Ranolazine Extended-Release Tablets (drug). According to the FDA report, the reason is: Failed Dissolution Specifications: below specification. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Lot / code info
- Lot: DJ25134, Exp 11/30/2028
- Quantity
- Not listed
- Distribution
- Nationwide in the US.
- Recalling company
- Ajanta Pharma USA Inc, Bridgewater, NJ United States
- Recall started
- September 17, 2026
- FDA report date
- October 7, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0010-2027
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Ajanta Pharma USA Inc) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.