Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc.,
BRP Pharmaceuticals recalls 50mg spironolactone tablets due to potential label mix-up with 25mg tablets. Consumers should check product details and contact the manufacturer for guidance.
Lower-risk recall
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Contact the company & request your remedy
What happened, in plain English
BRP Pharmaceuticals is recalling 50mg spironolactone tablets that may contain 25mg tablets due to a labeling error. This could lead to incorrect dosing if taken without proper knowledge of the actual strength. Read more at govinfonow.com/recall/36541-brp-pharmaceuticals-spironolactone-50mg-tablets-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36541-brp-pharmaceuticals-spironolactone-50mg-tablets-recall-label-mix-up-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0304-2021
Cite this page
“BRP Pharmaceuticals Spironolactone 50mg Tablets Recall: Label Mix-Up Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36541-brp-pharmaceuticals-spironolactone-50mg-tablets-recall-label-mix-up-risk. Based on FDA recall #D-0304-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0304-2021%22&limit=1).
Why it’s dangerous
The labeling error means that some bottles labeled as 50mg spironolactone may actually contain 25mg tablets. This could cause incorrect dosing if the user takes the tablets without knowing the actual strength.
Who’s affected
People who have the 30-count bottles of 50mg spironolactone tablets from this manufacturer. Those taking spironolactone for medical reasons are most at risk if they unknowingly take a different dose.
How to tell if you have this one
Check for the 30-count bottles labeled 'Spironolactone Tablets, USP, 50 mg' with NDC 63629-1067-01. The lot number is 148992, expiring May 31, 2022.
- Brand
BRP Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | Class |
|---|---|---|---|
| D-0303-2021 | 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; a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022 | 35 bottles | Class I |
| D-0304-2021 | 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; Lot #: 148992, Exp 5/31/2022 | 12 bottles | Class II |
What to do — step by step
Check Product Details
Look for the NDC code 63629-1067-01 and lot number 148992 on the bottle.
Questions people ask
What is the risk of taking the wrong dose?
The recall indicates that some bottles labeled as 50mg may contain 25mg tablets. Taking the wrong dose could lead to incorrect medication levels.
How can I check if my tablets are affected?
Check for the NDC code 63629-1067-01 and lot number 148992 on the bottle. This is the specific batch that was recalled.
Do I need to stop using the tablets immediately?
No, the recall does not require immediate discontinuation. Check the product details and contact the manufacturer if you have concerns.
Contact BRP Pharmaceuticals
We’ve drafted a message you can send BRP Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0304-2021 — BRP Pharmaceuticals BRP Pharmaceuticals Hello, I own a BRP Pharmaceuticals that is covered by recall D-0304-2021 from BRP Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0304-2021 (January 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0304-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.