Lupin Recalls Tri-Lo-Marzia Due to CGMP Deviations
Lupin Pharmaceuticals recalls specific lots of Tri-Lo-Marzia tablets due to blend uniformity issues. Check your lot number and expiration date.
Recall notice
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals Inc. is recalling Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets) because of Good Manufacturing Practice deviations related to out-of-specification test results for blend uniformity. The recall affects specific lots distributed nationwide in the United States. No remedy or return instructions are currently provided in the record. Read more at govinfonow.com/recall/37478-lupin-recalls-tri-lo-marzia-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/37478-lupin-recalls-tri-lo-marzia-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0790-2020
Cite this page
“Lupin Recalls Tri-Lo-Marzia Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37478-lupin-recalls-tri-lo-marzia-due-to-cgmp-deviations. Based on FDA recall #D-0790-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0790-2020%22&limit=1).
Why it’s dangerous
The hazard stems from CGMP deviations where retrospective review of blend uniformity test data revealed out-of-specification results. This means the active ingredients might not be evenly distributed throughout the tablets, potentially affecting dosage consistency.
Who’s affected
Consumers in the United States who have purchased Tri-Lo-Marzia tablets from the affected lots may be impacted. As a prescription medication, these users are most at risk of receiving product that does not meet uniformity specifications.
How to tell if you have this one
Check your package for the brand name Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP). Look for Lot # L800498 with an expiration date of February 2020. The product is distributed by Lupin Pharmaceuticals, Inc., Baltimore MD.
- Brand
Lupin- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide in the US” 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 III
- 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
How can I identify if I have the affected product?
Look for Tri-Lo-Marzia tablets with NDC 68180-837-13 (3x28 carton) or NDC 68180-837-11 (28 tablet wallet), distributed by Lupin Pharmaceuticals, Inc.
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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-0790-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0790-2020 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.