Nortrel Oral Contraceptive Tablets Recalled for Discolored Inert Remainder Tablets
Teva Pharmaceuticals is recalling 12,916 cartons of Nortrel oral contraceptive tablets nationwide due to discolored inert remainder tablets that may cause confusion. Affected lot: #100042978, expiration 7/31/2024.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is purely cosmetic discoloration of inert remainder tablets. Per the severity rubric, FDA Class III recalls are typically scored 1–2, and cosmetic defects score 1.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 12,916 cartons of Nortrel (norethindrone and ethinyl estradiol) 0.5/35 mg tablets nationwide. The affected lot is #100042978 with an expiration date of July 31, 2024. Each carton contains three blister cards with 28 tablets per card. The recalled cartons contain discolored tablets in shades of blue mixed in with the white inert remainder tablets.
The inert remainder tablets serve as a visual marker to help patients maintain proper medication sequencing. Discolored inert tablets may cause confusion about which tablets are active versus inactive when taking their medication.
Patients currently taking Nortrel should check their blister pack for the affected lot number and expiration date. Patients should contact their pharmacist or healthcare provider if they have questions about whether their medication is part of the recall. Patients should continue taking their medication as prescribed.
The recalled product
- Product
- NORTREL (NORETHINDRONE AND ETHINYL ESTRADIOL)
- Brand
- NORTREL
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 12,916
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 100042978
- Exp 7/31/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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