Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets Recalled by Lupin Pharmaceuticals Inc. Due to CGMP Deviations: Out of specification test result observed...

Date: January 10, 2020
Company: Lupin Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.

Affected Products

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)

Quantity: 34,080 boxes (3 wallets per carton, 80 cartons per box)

Why Was This Recalled?

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report