FirmLabelled 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.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list HTO Nevada, Inc. with 5 drug recalls and 1 warning letter. The most recent is a warning letter dated Jan 27, 2026: Warning letter: Process validation, Method validation, Stability.
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.
| Jan 27, 2026 | Warning letter: Process validation, Method validation, StabilityCDER | Warning letters |
| Feb 9, 2023 | Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.derClass II · cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | Drug recalls |
| Feb 9, 2023 | New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source,Class II · cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | Drug recalls |
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
