CLASS I ONGOING Drug recall · Reported 24 Mar 2021 · FDA Enforcement Report

Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack

Bryant Ranch Prepack is recalling Spironolactone Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 27 Jan 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022

Quantity recalled35 bottles

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-0303-2021
FDA event ID: 87283
Recalling firm: Bryant Ranch Prepack, Burbank, CA
Classification: Class I
Status: Ongoing
Recall initiated: 27 Jan 2021
FDA classified: 16 Mar 2021
Reported: 24 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
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 25 mg may contain spironolactone 50 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, 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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.

Which lots are affected?

a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 87283

This product is part of a recall event; the main page for the event is Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack.

Reported	Class	Recall	Company	Reason	Where
24 Mar 2021	CLASS II	Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack	Bryant Ranch Prepack	Packaging Defects	Nationwide

More recalls from Bryant Ranch Prepack

All 17

Reported	Class	Recall	Company	Reason	Where
12 Jun 2024Drug	CLASS III	Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin	Bryant Ranch Prepack	Other	Nationwide
12 Jun 2024Drug	CLASS III	Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin	Bryant Ranch Prepack	Other	Nationwide
12 Jun 2024Drug	CLASS III	Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin	Bryant Ranch Prepack	Other	Nationwide
12 Jun 2024Drug	CLASS III	Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin	Bryant Ranch Prepack	Other	Nationwide
12 Jun 2024Drug	CLASS III	Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin	Bryant Ranch Prepack	Other	Nationwide

Other Spironolactone recalls

All 8

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Spironolactone Tablets, USP, 25 mg recalledSpironolactone	SUN Pharmaceutical Industries	Other	Nationwide
22 Sep 2021Drug	CLASS II	Spironolactone Ophthalmic Solution 0.005 mg/mL recalled	Prescription Labs	Sterility	Nationwide
24 Mar 2021Drug	CLASS II	Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack	Bryant Ranch Prepack	Packaging Defects	Nationwide
20 May 2015Drug	CLASS II	Spironolactone 5 mg/mL Susp, Health Innov Pharmacy recalled	Health Innovations Pharmacy	Sterility	NC
27 Nov 2013Drug	CLASS II	Spironolactone tablets, USP 50 mg recalled by Greenstone	Greenstone	Potency & Assay	Nationwide