Lupin Recalls Lisinopril/HCTZ Tablets Due to CGMP Deviations
Lupin Pharmaceuticals recalls specific lots of Lisinopril and Hydrochlorothiazide tablets due to manufacturing deviations. Check your bottle's NDC and lot number.
Use caution until it’s fixed
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals Inc. is recalling Lisinopril & Hydrochlorothiazide Tablets, USP 20mg/12.5mg because of Current Good Manufacturing Practice (CGMP) deviations. The finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. This recall affects specific lots distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43015-lupin-recalls-lisinopril-hctz-tablets-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/43015-lupin-recalls-lisinopril-hctz-tablets-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-1052-2016
Cite this page
“Lupin Recalls Lisinopril/HCTZ Tablets Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43015-lupin-recalls-lisinopril-hctz-tablets-due-to-cgmp-deviations. Based on FDA recall #D-1052-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1052-2016%22&limit=1).
Why it’s dangerous
The hazard stems from CGMP deviations where active pharmaceutical ingredients were used despite their intermediates failing specifications. This means the chemical composition or purity of the drug may not be consistent with regulatory standards, potentially affecting its efficacy or safety profile.
Who’s affected
Patients who have been prescribed Lisinopril & Hydrochlorothiazide Tablets by Lupin Pharmaceuticals Inc. are affected. Individuals possessing the specific lot numbers listed below are at risk of receiving a product that did not meet manufacturing specifications.
How to tell if you have this one
Check your medication bottle for NDC numbers 68180-519-01 (100-count bottles) or 68180-519-30 (5000-count bottles). Verify the lot numbers are H303459 or H303460 and that the expiration date is 09/2016. The product was manufactured for Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Lisinopril & Hydrochlorothiazide Tablets match the recalled NDCs (68180-519-01 or 68180-519-30) and lot numbers (H303459 or H303460).
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider to discuss replacement options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide 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 14 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.
Similar recalls
Other Lupin Pharmaceuticals recalls
Keep exploring
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-1052-2016 (April 4, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1052-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.