CLASS III Drug recall · Reported 17 Jul 2013 · FDA Enforcement Report
Balziva(TM) (norethindrone and ethinyl estradiol tablets recalled
Teva Pharmaceuticals USA is recalling Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 15 mg/0.03 mg, 28 day, distributed nationwide in the US. The recall was initiated on 15 Mar 2013 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-684-2013
- FDA event ID
- 64644
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Balziva
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Mar 2013
- FDA classified
- 5 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Benzene
- Drug class
- Hormones & Birth Control
Timeline
| 15 Mar 2013 | Recall initiated by company | |
| 5 Jul 2013 | Classified by FDA | +112 days |
| 17 Jul 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product as listed by the FDA
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
Where it was distributed
Nationwide distribution. No foreign or government accounts.
Questions about this recall
Is Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 15 mg/0.03 mg, 28 day recalled?
Yes. Teva Pharmaceuticals USA recalled Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 15 mg/0.03 mg, 28 day on 15 Mar 2013. The recall is Class III and its status is Terminated. Recall number D-684-2013.
Why was it recalled?
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Which lots are affected?
NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.
Where was it sold?
Nationwide distribution. No foreign or government accounts.
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.
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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 III | Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35 recalledNortrel | 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 |