Sandoz Potassium Chloride Recall: Wrong Package Insert
Cardinal Health recalls Sandoz Potassium Chloride tablets due to incorrect package inserts. Check your lot numbers and expiration dates for details.
Use caution until it’s fixed
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
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What happened, in plain English
Cardinal Health is recalling specific lots of Sandoz Potassium Chloride, microencapsulated extended-release tablets (20 mEq) because the wrong package insert was included in the packaging. The insert provided corresponds to different strengths (8 mEq and 10 mEq) rather than the actual product strength (10 mEq and 20 mEq). This labeling error could lead to confusion regarding dosage instructions. Read more at govinfonow.com/recall/46573-cardinal-health-recalls-potassium-chloride-microencapsulated-extended-release-tablets-20.
Source Summary by GovInfoNow · govinfonow.com/recall/46573-cardinal-health-recalls-potassium-chloride-microencapsulated-extended-release-tablets-20 · Updated October 13, 2026 · FDA enforcement record: FDA #D-0489-2015
Cite this page
“Sandoz Potassium Chloride Recall: Wrong Package Insert.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46573-cardinal-health-recalls-potassium-chloride-microencapsulated-extended-release-tablets-20. Based on FDA recall #D-0489-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0489-2015%22&limit=1).
Why it’s dangerous
The hazard is that the package insert inside the box describes different drug strengths than what is actually in the blister cards. This mismatch means patients might not have accurate instructions on how to take their specific dose, potentially leading to medication errors or confusion about proper usage.
Who’s affected
Patients who have been prescribed or purchased Sandoz Potassium Chloride extended-release tablets from the affected lots. These individuals may possess incorrect usage information for their specific medication strength.
How to tell if you have this one
Look for Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, in a blister card of 30/10 cards in a corrugated shipper. Check the lot numbers: 315004A or 315620A, both with an expiration date of 1/15/14. The product was manufactured by Upsher-Smith Laboratories, Inc. for Sandoz, Inc.
- Brand
Sandoz- Category
Drug
Where it went and when
Where it was distributed
Distributed in Oklahoma.
FDA distribution: “OK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Oklahoma.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0489-2015 (October 2, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0489-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.