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.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Crown Laboratories with 6 drug applications and 2 drug recalls. The most recent is a drug recall dated Jun 10, 2020: Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distrib….
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.
| Jun 10, 2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 3Class II · Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Drug recalls |
| Jun 10, 2020 | Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37Class II · Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | 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