Lupin Recalls Lisinopril 40mg Due to CGMP Deviations
Lupin Pharmaceuticals recalls 5,880 bottles of Lisinopril 40 mg tablets due to manufacturing deviations. Check your bottle's lot number and expiration date.
Recall notice
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 5,880 bottles of Lisinopril Tablets USP, 40 mg because the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. This is a Class III recall involving Rx-only medication distributed domestically in the US. The record does not specify the exact health risks or provide a remedy for consumers. Read more at govinfonow.com/recall/43012-lupin-recalls-lisinopril-40mg-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/43012-lupin-recalls-lisinopril-40mg-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-1503-2016
Cite this page
“Lupin Recalls Lisinopril 40mg Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43012-lupin-recalls-lisinopril-40mg-due-to-cgmp-deviations. Based on FDA recall #D-1503-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1503-2016%22&limit=1).
Why it’s dangerous
The hazard stems from CGMP (Current Good Manufacturing Practice) deviations where active pharmaceutical ingredients were used despite their intermediates failing specifications. The record does not describe the specific nature of these failures or the potential impact on the drug's safety or efficacy.
Who’s affected
Consumers in the United States who purchased 1000-count bottles of Lupin's Lisinopril 40 mg tablets between the manufacturing date and April 6, 2016. Patients relying on this specific batch for blood pressure or heart conditions are most affected.
How to tell if you have this one
Look for 1000-count bottles of Lisinopril Tablets USP, 40 mg, manufactured by Lupin Limited in India for Lupin Pharmaceuticals Inc. The specific recalled lot number is H303449 with an expiration date of 09/16. The NDC code is 68180-517-03.
- Brand
Lupin- 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 III- Status
Terminated- Distribution
All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.- NDC
68180-512-02, 68180-512-30, 68180-512-09, 68180-512-01, 68180-512-03, 68180-513-30, 68180-513-03, 68180-513-01, 68180-513-09, 68180-513-02, 68180-513-05, 68180-517-03, 68180-517-01, 68180-517-30, 68180-517-09, 68180-517-04, 68180-517-02, 68180-980-03, 68180-980-30, 68180-980-01, 68180-980-09, 68180-980-05, 68180-980-02, 68180-981-01, 68180-981-03, 68180-981-30, 68180-981-09, 68180-981-02, 68180-981-05, 68180-982-01, 68180-982-02, 68180-982-30, 68180-982-03, 68180-982-09, 68180-979-01, 68180-979-03, 68180-979-30, 68180-979-09, 68180-514-01, 68180-514-02, 68180-514-03, 68180-514-09, 68180-514-30, 68180-514-05, 68180-515-01, 68180-515-02, 68180-515-03, 68180-515-09, 68180-515-30, 68180-515-05, 68180-516-01, 68180-516-02, 68180-516-03, 68180-516-09, 68180-516-30
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1502-2016 | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.; Batch number: H303487, H303488, H303489, Exp 09/16 | 20,556 bottles |
| D-1503-2016 | Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.; Batch number: H303449, Exp 09/16 | 5,880 bottles |
How this recall unfolded
Recall timeline
FDA terminated this recall 16 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-1503-2016 (April 6, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1503-2016 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.