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fda_recall · drug_recall · high

Ajanta Pharma USA Inc — Class II recall: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed…

Event date
2026-10-07 00:00:00Z
Observed
2026-10-13 04:20:22Z
Source ID
D-0010-2027
Payload hash
b55733c84a8d43dff069d13a…

Summary

Failed Dissolution Specifications: below specification Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Ajanta Pharma USA Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 4 total FDA actions tied to Ajanta Pharma USA Inc: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-10-07; Argus observed and indexed it on 2026-10-13.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Ajanta Pharma USA Inc — Class II recall: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0010-2027
MLA
"Ajanta Pharma USA Inc — Class II recall: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0010-2027.
Chicago
Argus HQ Research. "Ajanta Pharma USA Inc — Class II recall: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed…." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0010-2027.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ajanta_pharma_usa_inc_d_0010_2027_2026,
  title = {Ajanta Pharma USA Inc — Class II recall: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0010-2027},
  note = {Accessed: October 13, 2026}
}

Informational only. Not legal, financial, or medical advice.

Ajanta Pharma USA Inc — Class II recall: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed… · Argus HQ