CLASS III Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets recalled
Lupin Pharmaceuticals is recalling Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg, distributed nationwide in the US. The recall was initiated on 10 Jan 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0790-2020
- FDA event ID
- 84674
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Jan 2020
- FDA classified
- 17 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 10 Jan 2020 | Recall initiated by company | |
| 17 Jan 2020 | Classified by FDA | +7 days |
| 22 Jan 2020 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
Where it was distributed
Distributed nationwide in the US
Questions about this recall
Why was it recalled?
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Which lots are affected?
Lot # L800498, exp. date February 2020
Where was it sold?
Distributed nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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