Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

VENSUN PHARMACEUTICALS INC: Potassium Citrate Extended-Release Tablets Recalled for Tablet Breakage

Agency Publication Date: July 27, 2018
Share:
Sign in to monitor this recall

Summary

Vensun Pharmaceuticals is recalling approximately 15,335 bottles of Potassium Citrate Extended-Release Tablets (potassium citrate) because the tablets may break or crumble. This recall affects 100-count bottles of both 10 mEq and 15 mEq strengths that were distributed across the United States and Puerto Rico. When an extended-release tablet breaks, it can interfere with how the medication is absorbed by the body, potentially leading to serious health complications. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lots.

Risk

Broken extended-release tablets can cause the medication to be released into the bloodstream all at once rather than slowly over time. This 'dose dumping' can lead to dangerously high levels of potassium in the blood or cause irritation and injury to the digestive tract.

What You Should Do

  1. Check your prescription bottles to identify if you have Potassium Citrate Extended-Release Tablets, USP, 15 mEq or 10 mEq in 100-count bottles.
  2. For the 15 mEq strength, look for NDC 42543-408-01 and the following lot numbers: 9570024 (Exp. Jun-2019), 9570027 (Exp. Jul-2019), 9570029 (Exp. Jul-2019), 7702088A (Exp. Aug-2019), or 7702089A (Exp. Aug-2019).
  3. For the 10 mEq strength, look for NDC 42543-407-01 and lot number 9570012 with an expiration date of June-2019.
  4. If your medication matches these details, contact your healthcare provider or pharmacist immediately for guidance and to obtain a replacement prescription. Do not stop taking your medication without consulting a professional.
  5. Return any unused or broken tablets to the pharmacy where they were purchased for a refund.
  6. Contact Vensun Pharmaceuticals at their Yardley, Pennsylvania office for further instructions regarding the return of the product.
  7. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Return for refund and medical consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Potassium Citrate Extended-Release Tablets, USP, 15 mEq (100-count bottles)
Model:
NDC 42543-408-01
Recall #: D-1017-2018
Lot Numbers:
9570024 (Exp. Jun-2019)
9570027 (Exp. Jul-2019)
9570029 (Exp. Jul-2019)
7702088A (Exp. Aug-2019)
7702089A (Exp. Aug-2019)
Date Ranges: June 2019 - August 2019
Product: Potassium Citrate Extended-Release Tablets, USP, 10 mEq (100-count bottles)
Model:
NDC 42543-407-01
Recall #: D-1018-2018
Lot Numbers:
9570012 (Exp. June-2019)
Date Ranges: June 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80553
Status: Resolved
Manufacturer: VENSUN PHARMACEUTICALS INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (11,652 bottles; 3,683 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.