CLASS II ONGOING Drug recall · Reported 24 Mar 2021 · FDA Enforcement Report
Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack
Bryant Ranch Prepack is recalling Spironolactone Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 27 Jan 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0304-2021
- FDA event ID
- 87283
- Recalling firm
- Bryant Ranch Prepack, Burbank, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jan 2021
- FDA classified
- 16 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 27 Jan 2021 | Recall initiated by company | |
| 16 Mar 2021 | Classified by FDA | +48 days |
| 24 Mar 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Spironolactone Tablets, USP, 50 mg recalled?
Yes. Bryant Ranch Prepack recalled Spironolactone Tablets, USP, 50 mg on 27 Jan 2021. The recall is Class II and its status is Ongoing. Recall number D-0304-2021.
Why was it recalled?
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Which lots are affected?
Lot #: 148992, Exp 5/31/2022
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bryant Ranch Prepack
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
Other Spironolactone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Spironolactone Tablets, USP, 25 mg recalledSpironolactone | Sun Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS I | Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone tablets, USP 50 mg recalled by Greenstone | Greenstone | Potency & Assay | Nationwide |
| Drug | CLASS II | Aldactone (spironolactone) tablets, USP, 100 mg recalledAldactone | Pfizer Us Pharmaceutical Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Spironolactone tablets, USP 25 mg recalled by Greenstone | Greenstone | Potency & Assay | Nationwide |