Sandoz Recalls Lisinopril 30mg Due to Missing Label Insert
Sandoz recalls 3,048 bottles of Lisinopril 30mg tablets because the package insert is incorrect or missing. Check your lot number and expiration date.
Use caution until it’s fixed
Labeling: Incorrect or Missing Package Insert
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What happened, in plain English
Sandoz Inc. has recalled one lot of Lisinopril Tablets USP, 30 mg, sold in 100-count bottles. The issue is that the package insert included with the medication is either incorrect or missing entirely. This recall affects 3,048 bottles distributed nationwide. Read more at govinfonow.com/recall/42602-sandoz-recalls-lisinopril-30mg-due-to-missing-label-insert.
Source Summary by GovInfoNow · govinfonow.com/recall/42602-sandoz-recalls-lisinopril-30mg-due-to-missing-label-insert · Updated October 9, 2026 · FDA enforcement record: FDA #D-1036-2016
Cite this page
“Sandoz Recalls Lisinopril 30mg Due to Missing Label Insert.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42602-sandoz-recalls-lisinopril-30mg-due-to-missing-label-insert. Based on FDA recall #D-1036-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1036-2016%22&limit=1).
Why it’s dangerous
The hazard is that patients may lack the necessary package insert, which contains critical information on how to take the medication, potential side effects, and storage instructions. Without this document, users might misuse the drug or miss important safety warnings.
Who’s affected
Patients who have been prescribed Lisinopril 30 mg by Sandoz and possess a bottle from the specific recalled lot. These individuals are at risk of not having proper instructions for use or safety information.
How to tell if you have this one
Check your bottle for the brand Sandoz, the strength of 30 mg, and a 100-count package. Look specifically for NDC 0185-0630-01, Lot # FC1960, and an expiration date of 02/18.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Lisinopril bottle matches NDC 0185-0630-01, Lot # FC1960, and Exp. 02/18.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacy or healthcare provider for instructions on how to return or replace it.
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 11 months 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-1036-2016 (May 25, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1036-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.