Sandoz Recalls Fosinopril Sodium and Hydrochlorothiazide Tablets
Sandoz recalls specific lots of Fosinopril Sodium and Hydrochlorothiazide Tablets due to subpotent Hydrochlorothiazide levels.
Use caution until it’s fixed
Subpotent; Hydrochlorothiazide at the 9 month time point.
Contact the company
What happened, in plain English
Sandoz Inc is recalling one lot of Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, because the Hydrochlorothiazide component may be subpotent at the 9-month time point. This means the medication might not contain enough of the active ingredient to work as intended. The recall affects 2,491 bottles distributed nationwide. Read more at govinfonow.com/recall/46556-sandoz-inc-recalls-fosinopril-sodium-and-hydrochlorothiazide-tablets-10-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/46556-sandoz-inc-recalls-fosinopril-sodium-and-hydrochlorothiazide-tablets-10-mg · Updated October 13, 2026 · FDA enforcement record: FDA #D-393-2014
Cite this page
“Sandoz Recalls Fosinopril Sodium and Hydrochlorothiazide Tablets.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46556-sandoz-inc-recalls-fosinopril-sodium-and-hydrochlorothiazide-tablets-10-mg. Based on FDA recall #D-393-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-393-2014%22&limit=1).
Why it’s dangerous
The hazard is that the Hydrochlorothiazide in the tablets is subpotent, meaning it contains less of the active drug than labeled. This could lead to inadequate control of blood pressure or fluid retention if relied upon without medical adjustment.
Who’s affected
Patients currently taking this specific prescription medication for blood pressure or heart conditions are affected. Those who have used the recalled lot may receive less effective treatment than expected.
How to tell if you have this one
Check your medication bottle for NDC 0185-0341-01 and Lot number CU0856. The product is Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, in bottles of 100 tablets.
- Brand
Sandoz- Category
Drug
What to do — step by step
Contact Your Doctor
Speak with your healthcare provider immediately to discuss whether you should continue taking this medication or switch to a different product.
Check Your Bottle
Verify if your bottle has NDC 0185-0341-01 and Lot CU0856 to confirm if it is part of this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 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.
Questions people ask
Who is manufacturing this product?
Sandoz Inc, located in Princeton, NJ, is the manufacturer recalling these tablets.
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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-393-2014 (October 11, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-393-2014 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.