Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IndiaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 9 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Aurobindo Pharma and its 9 subsidiaries with 865 drug applications, 144 drug recalls, 5 warning letters and 3 complete response letters. The most recent is a warning letter dated Aug 13, 2026: Warning letter: Aseptic processing, Sterility assurance, Environmental monitoring.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Aurobindo Pharma and its 9 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 13, 2026 | Warning letter: Aseptic processing, Sterility assurance, Environmental monitoringCDER | Warning letters |
| Nov 13, 2025 | Warning letter: DrugsCDER | Warning letters |
| Oct 1, 2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber PClass II · Presence of Particulate Matter: Particulate matter identified as glass | Drug recalls |
| Aug 15, 2024 | Warning letter: Data integrity, Aseptic processing, Sterility assuranceCDER | Warning letters |
| Feb 9, 2023 | Warning letter: DrugsCDER | Warning letters |
| Jan 12, 2022 | Warning letter: Out-of-specification, Quality unitCDER | Warning letters |
| Oct 1, 2019 | Complete response letter, NDA 210735Approved | Complete response letters |
| Jun 20, 2019 | Warning letter: Out-of-specification, Quality unitCDER | Warning letters |
| Jan 15, 2019 | Complete response letter, NDA 210735Approved | Complete response letters |
| Apr 26, 2018 | Complete response letter, NDA 210735Approved | Complete response letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
