Ajanta Pharma USA Inc. is recalling Ranolazine Extended-Release Tablets, 1000 mg, in 60-count bottles because they failed dissolution specifications. The affected product has NDC 27241-126-02 and Lot DJ25134 with an expiration date of 11/30/2028. This recall was issued on September 17, 2026, and affects products distributed nationwide in the US. Read more at govinfonow.com/recall/1443830-ajanta-pharma-usa-inc-recalls-ranolazine-extended-release-tablets-1000.
“Ajanta Pharma Recalls Ranolazine 1000mg Due to Dissolution Failure.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/1443830-ajanta-pharma-usa-inc-recalls-ranolazine-extended-release-tablets-1000. Based on FDA recall #D-0010-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0010-2027%22&limit=1).
The FDA announced on Sept. 17, 2026, that Ajanta Pharma USA Inc. is voluntarily recalling Ranolazine Extended-Release Tablets, 1000 mg, due to failed dissolution specifications. The agency issued recall number D-0010-2027 for the Class II recall.
The recall is due to Ranolazine Extended-Release Tablets failing dissolution specifications, falling below the required standard. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Ajanta Pharma USA Inc. has issued three other recalls since May 27, 2026. Other recent recalls of similar products include Lannett Niacin Extended-release Tablets Recall (May 27, 2026), Golden State Recalls Niacin 1000mg Due to Dissolution Failure (Oct. 20, 2025), and Inventia Chlorthalidone Recall (Sept. 3, 2026).
How to tell if you have this one
Check your medication bottle for NDC 27241-126-02 and Lot DJ25134. The product is Ranolazine Extended-Release Tablets, 1000 mg, in a 60-count bottle, marketed by Ajanta Pharma USA Inc.
Brand
Ajanta Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Your Pharmacist
Reach out to your pharmacy or healthcare provider to discuss the recall and obtain guidance on replacing the medication.
Do Not Stop Medication Abruptly
Consult your doctor before making any changes to your dosage or stopping the medication, as sudden cessation can be harmful.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the US.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0010-2027 (September 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0010-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.