FDA Drug recall D-0010-2027
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807
- FDA Drug
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807 by Ajanta Pharma Usa, citing failed Dissolution Specifications: below specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0010-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-17 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Ajanta Pharma Usa |
| Distribution | US |
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
Identifiers
| ndc | 27241-125-02 |
|---|---|
| ndc | 27241-125-05 |
| ndc | 27241-126-02 |
| ndc | 27241-126-05 |
| code_info | Lot: DJ25134, Exp 11/30/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
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FDA Drug · Class III · 2026-09-16 · Ajanta Pharma Usa - Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc
FDA Drug · Class II · 2026-07-01 · Ajanta Pharma Usa - Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-…
FDA Drug · Class II · 2026-06-24 · Ajanta Pharma Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0010-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.