Ajanta Pharma recall: Ranolazine Extended-Release Tablets
Ajanta Pharma USA Inc is recalling Ranolazine Extended-Release Tablets. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on September 17, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Ranolazine Extended-Release Tablets |
| Brand | Ajanta Pharma |
| Company | Ajanta Pharma USA Inc |
| Type | Drugs |
| Classification | Class II |
| Recall date | September 17, 2026 |
| Published by FDA | October 7, 2026 |
| Recall ID | 99893 |
Recalled products
- Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
- FDA recall number
- D-0010-2027
- Codes, lots and dates
- Lot: DJ25134, Exp 11/30/2028
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99893
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Bridgewater, NJ, United States
Why it was recalled
The reason the FDA lists: “Failed Dissolution Specifications: below specification”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide in the US.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99893, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Ajanta Pharma recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 16, 2026 |  Ajanta Pharma recall: Fluphenazine Hydrochloride TabletsDrugs · 403,200 tablets | Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impuri… Lower risk | FDA Class III |
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
| Oct 7, 2026 | SV Labs Toronto recall: Benzoyl Peroxide WashDrugs | microbial contamination Serious | FDA Class II |
About this recall
Is Ajanta Pharma Ranolazine Extended-Release Tablets recalled?
Yes. Ajanta Pharma USA Inc recalled it on September 17, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Dissolution Specifications: below specification
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.