Lower risk Drug recall · FDA · Published January 25, 2024

Teva Nortrel 0.5/35 Tablets Recall: Discolored Tablets Risk

Teva recalls Nortrel 0.5/35 tablets with discolored (blue) tablets mixed in. Affected units have specific NDC and lot numbers. Stop using if you see discoloration.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0321-2024Drug Teva ›

Lower-risk recall

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120

✎ GovInfoNow plain-language explainer

Teva is recalling Nortrel 0.5/35 tablets that may contain discolored blue tablets. This could be a safety issue if the discolored tablets are taken, though the recall doesn't specify a risk of injury. Read more at govinfonow.com/recall/32848-teva-nortrel-0-5-35-tablets-recall-discolored-tablets-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32848-teva-nortrel-0-5-35-tablets-recall-discolored-tablets-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0321-2024

Cite this page

“Teva Nortrel 0.5/35 Tablets Recall: Discolored Tablets Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32848-teva-nortrel-0-5-35-tablets-recall-discolored-tablets-risk. Based on FDA recall #D-0321-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0321-2024%22&limit=1).

The FDA announced on Jan. 25, 2024, that Teva Pharmaceuticals USA, Inc. is recalling Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 due to discolored blue tablets mixed with white inert remainder tablets. The recall affects 12,916 cartons distributed nationwide.

How to tell if you have it

Brand: Teva
Product: Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35
NDC: 0555-9008-67
Lot #: 100042978
Expiration Date: 7/31/2024
Quantity: 12,916 cartons

The hazard

The hazard involves discolored tablets appearing in shades of blue mixed within the white inert remainder tablets. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Bionpharma Divalproex Tablets Recall (June 26, 2026), Glenmark Nebivolol Tablets Recall (Nov. 18, 2025), and Zydus Mirabegron 25mg Tablets Recall (Aug. 5, 2026).

How to tell if you have this one

Check for blue or discolored tablets in the carton. The affected product has NDC 0555-9008-67 and lot number 100042978, expiring July 31, 2024.

Brand
Teva
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Ongoing
Distribution
nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0321-2024	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; Lot #: 100042978, Exp 7/31/2024	12,916 cartons	0555-9009-80, 0555-9009-42, 0555-9010-79, 0555-9010-58, 0555-9008-79, 0555-9008-67
D-0322-2024	Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58; Lot #: 100040731, Exp 7/31/2024	19,824 cartons	0555-9012-79, 0555-9012-58

Based on the official FDA remedy

What to do — step by step

Check for Discolored Tablets
Look for blue or discolored tablets mixed with white tablets in the carton.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

Jan 25, 2024Firm started the recall
Feb 12, 2024FDA classified it Class III
Feb 21, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Teva recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32848-teva-nortrel-0-5-35-tablets-recall-discolored-tablets-risk">Teva Nortrel 0.5/35 Tablets Recall: Discolored Tablets Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0321-2024 (January 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0321-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.