Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change
Greenstone LLC is recalling 4,848 bottles of Spironolactone 50 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4).
Plain-English summary
Greenstone LLC is recalling 4,848 bottles of Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle (NDC: 59762-5012-1). The affected product is identified by Lot # V121211 with an expiration date of 03/31/2017. The recall is being initiated because changes to the dissolution profile in the distributed lots resulted from a manufacturing site change, and there is currently no approved application supporting the alternate manufacturing site.
The affected product was distributed nationwide and in Puerto Rico. This recall is classified as FDA Class II. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- Product
- Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
- Manufacturer
- Greenstone Llc
- Category
- Drug — Prescription Medication
- Affected units
- 4,848
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 (2)
- Lot #: V121211
- Exp 03/31/2017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Greenstone Llc 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 →Related recalls
Same manufacturer · Greenstone Llc
See all →- HighMethylprednisolone dose packs recalled over misoriented blister foil dosing information
FDA (Drugs) · 2026-02-04
- CriticalGreenstone Recalls Venlafaxine Capsules Due to Foreign Capsule Contamination
FDA (Drugs) · 2014-06-18
- LowGreenstone Recalls Glipizide XL Tablets Due to Dissolution Failure
FDA (Drugs) · 2014-02-12
- ModerateGreenstone Recalls Sertraline Tablets Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2014-01-29
- ModerateGreenstone Recalls Nifedipine Tablets Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2014-01-22
Same hazard · unapproved manufacturing
See all →- ModerateGreenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change
FDA (Drugs) · 2013-11-27
- ModeratePfizer Recalls Aldactone Tablets Due to Unapproved Manufacturing Site
FDA (Drugs) · 2013-11-27