Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 recall
FDA recall D-0321-2024 · initiated Jan 25, 2024
Teva Pharmaceuticals USA, Inc recalled Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 in Jan 2024 — an FDA Class III recall (D-0321-2024) because Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12,916 cartons
Details
- Product
- Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- nationwide
- Initiated
- Jan 25, 2024
- FDA report date
- Feb 21, 2024
Frequently asked
- Was Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 recalled?
- Teva Pharmaceuticals USA, Inc recalled Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 in Jan 2024 — an FDA Class III recall (D-0321-2024) because Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 recalled?
- Per the FDA enforcement record, the reason for recall D-0321-2024 was: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Is a recalled Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 are affected?
- Distributed: nationwide. The recall covers these lots — Lot #: 100042978, Exp 7/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0321-2024.