Fludrocortisone Acetate Tablets — Class II drug recall D-0601-2024
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2024-07-24, distributed nationwide. Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unkn
| Recall number | D-0601-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2024-06-28 |
| Classified | 2024-07-16 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 116,144 bottles |
| Reason classes | specification failure |
| NDC | 00555-0997-02 |
| Expiration dates | 2024-06-30, 2024-07-31, 2024-09-30, 2024-11-30 |
Product
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
Reason for recall
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0601-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.