Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Hikma Pharmaceuticals. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hikma Pharmaceuticals USA with 21 drug recalls, 4 drug applications and 4 complete response letters. The most recent is a drug recall dated Apr 7, 2026: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bot….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 7, 2026 | Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., BerClass II · This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored | Drug recalls |
| Dec 23, 2024 | Complete response letter, NDA 219357Unapproved | Complete response letters |
| Oct 21, 2024 | Complete response letter, NDA 219045Unapproved | Complete response letters |
| Jan 23, 2024 | Complete response letter, NDA 218258Unapproved | Complete response letters |
| Feb 28, 2020 | Complete response letter, NDA 212045Approved | 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
