Vensun Potassium Citrate Tablets Recall: Tablet Breakage Hazard
Vensun recalls 100-count Potassium Citrate Extended-Release Tablets due to tablet breakage risk. Rx-only product with specific lot number and expiration date.
Lower-risk recall
Failed Tablet/Capsule Specifications: Tablet breakage
Contact the company
What happened, in plain English
Vensun is recalling 100-count Potassium Citrate Extended-Release Tablets that may break during use. This could lead to inconsistent dosing or potential injury if the broken pieces are swallowed. Read more at govinfonow.com/recall/40342-vensun-potassium-citrate-tablets-recall-tablet-breakage-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/40342-vensun-potassium-citrate-tablets-recall-tablet-breakage-hazard · Updated October 6, 2026 · FDA enforcement record: FDA #D-1018-2018
Cite this page
“Vensun Potassium Citrate Tablets Recall: Tablet Breakage Hazard.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40342-vensun-potassium-citrate-tablets-recall-tablet-breakage-hazard. Based on FDA recall #D-1018-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1018-2018%22&limit=1).
Why it’s dangerous
The tablets may break during use, which could cause inconsistent potassium levels in the body. Broken pieces might be swallowed, leading to potential injury or incorrect dosing.
Who’s affected
Prescription patients who received the recalled Potassium Citrate Extended-Release Tablets from Vensun. Those with medical conditions requiring precise potassium levels are at higher risk.
How to tell if you have this one
Check for the 100-count bottles labeled 'Potassium Citrate Extended-Release Tablets, USP, 10 mEq'. The lot number 9570012 was manufactured in June 2019 and expires June 2019.
- Brand
Vensun- 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.
- Classification
Class II- Status
Terminated- Distribution
Within the United States and Puerto Rico.- NDC
42543-406-01, 42543-407-01, 42543-408-01
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1017-2018 | 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.; Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019. | 11,652 bottles |
| D-1018-2018 | Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.; Lot #: 9570012, Exp. June-2019 | 3,683 bottles |
What to do — step by step
Check Product Details
Look for the 100-count bottles with lot number 9570012 manufactured in June 2019.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Within the United States and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1018-2018 (July 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1018-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.