CLASS II Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report

Potassium Citrate Extended-Release Tablets, USP, 15 mEq recalled

Vensun Pharmaceuticals is recalling Potassium Citrate Extended-Release Tablets, USP, 15 mEq, distributed in Puerto Rico. The recall was initiated on 18 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.

NDC42543-406, 42543-407, 42543-408

UPC0342543408012, 0342543406018, 0342543407015

Quantity recalled11,652 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-1017-2018
FDA event ID: 80553
Recalling firm: Vensun Pharmaceuticals, Yardley, PA
Brand: Potassium Citrate
Manufacturer: Strides Pharma Inc.
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2018
FDA classified: 27 Jul 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons

Timeline

18 Jul 2018	Recall initiated by company
27 Jul 2018	Classified by FDA	+9 days
8 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Tablet/Capsule Specifications: Tablet breakage

Product as listed by the FDA

Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.

Where it was distributed

Within the United States and Puerto Rico.

Puerto Rico

Questions about this recall

Why was it recalled?

Failed Tablet/Capsule Specifications: Tablet breakage

Which lots are affected?

Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.

Where was it sold?

Within the United States and Puerto Rico.

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 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 80553

This product is part of a recall event; the main page for the event is Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalled.

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018	CLASS II	Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalledPotassium Citrate	Vensun Pharmaceuticals	Other	PR

More recalls from Vensun Pharmaceuticals

All 2

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018Drug	CLASS II	Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalledPotassium Citrate	Vensun Pharmaceuticals	Other	PR

Other Potassium recalls

All 18

Reported	Class	Recall	Company	Reason	Where
31 May 2023Drug	CLASS II	Potassium Acetate Injection, 2 mEq/mL recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
23 Sep 2020Drug	CLASS III	Potassium Acetate Injection, USP 40 mEq recalled	Exela Pharma Sciences	Packaging Defects	Nationwide
4 Dec 2019Drug	CLASS II	Potassium Phosphate, Monobasic, Crystal, NF recalled	Avantor Performance Materials	Potency & Assay	Nationwide
8 Aug 2018Drug	CLASS II	Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalledPotassium Citrate	Vensun Pharmaceuticals	Other	PR
26 Jul 2017Drug	CLASS II	Potassium PHOSphate in 0.9% Sodium Chloride Injection recalled	PharMedium Services	Sterility	Nationwide