Spironolactone Tablets — Class I drug recall D-0303-2021
Ongoing recall by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals, reported 2021-03-24, distributed nationwide. Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tab
| Recall number | D-0303-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals, Burbank, CA, United States |
| Recall initiated | 2021-01-27 |
| Classified | 2021-03-16 |
| Reported by FDA | 2021-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 35 bottles |
| Reason classes | labeling |
| NDC | 63629-1064-01, 63629-1064-02, 63629-1064-03 |
| Lot numbers | 148791, 148969, 148991 |
| Expiration dates | 2022-07-31 |
Product
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA
Reason for recall
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
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-0303-2021. 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.