CLASS III ONGOING Drug recall · Reported 21 Feb 2024 · FDA Enforcement Report
Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35 recalled
Teva Pharmaceuticals USA is recalling Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35, distributed nationwide in the US. The recall was initiated on 25 Jan 2024 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-0321-2024
- FDA event ID
- 93867
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Nortrel
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 25 Jan 2024
- FDA classified
- 12 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 25 Jan 2024 | Recall initiated by company | |
| 12 Feb 2024 | Classified by FDA | +18 days |
| 21 Feb 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Is Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35 recalled?
Yes. Teva Pharmaceuticals USA recalled Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35 on 25 Jan 2024. The recall is Class III and its status is Ongoing. Recall number D-0321-2024.
Why was it recalled?
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Which lots are affected?
Lot #: 100042978, Exp 7/31/2024
Where was it sold?
nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Norethindrone recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS III | Nortrel 7/7/7 (norethindrone recalled by Teva Pharmaceuticals USANortrel 7/7/7 | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Balziva 28 Day (norethindrone recalled by Cardinal HealthBalziva | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Balziva(TM) (norethindrone and ethinyl estradiol tablets recalledBalziva | Teva Pharmaceuticals USA | Benzene | Nationwide |