The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0303-2021·Announced 2021-03-24

Spironolactone Tablets Recalled Due to Potential Labeling Error

Bryant Ranch Prepack is recalling 35 bottles of Spironolactone 25 mg tablets because they may contain 50 mg tablets.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals is recalling 35 bottles of Spironolactone Tablets, USP, 25 mg. The recall is due to a labeling error where bottles labeled as 25 mg may actually contain 50 mg tablets.

The affected product is manufactured by Frontida BioPharm, Inc. and repackaged by Bryant Ranch Prepack, Inc. The recall covers 30-count, 60-count, and 90-count bottles distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall documentation.

Consumers should check their medication bottles for the specific NDC and lot numbers associated with this recall. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

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…
Manufacturer
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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