Raloxifene Hydrochloride Tablets — Class II drug recall D-0854-2020
Terminated recall by American Health Packaging, reported 2020-02-19, distributed nationwide. Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
| Recall number | D-0854-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-12-04 |
| Classified | 2020-02-21 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2022-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 973 cartons |
| Reason classes | specification failure |
| NDC | 60687-0266, 60687-0266-11, 60687-0266-21 |
| Lot numbers | 180276A |
| Expiration dates | 2020-02-29 |
Product
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
Reason for recall
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
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-0854-2020. 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.