CLASS III Drug recall · Reported 23 Jul 2014 · FDA Enforcement Report
Velivet (desogestrel and ethinyl estradiol tablets recalled
Teva Pharmaceuticals U is recalling Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 1 mg/0.025 mg, distributed nationwide in the US. The recall was initiated on 17 Jun 2014 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-1439-2014
- FDA event ID
- 68610
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Brand
- Velivet
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jun 2014
- FDA classified
- 17 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 17 Jun 2014 | Recall initiated by company | |
| 17 Jul 2014 | Classified by FDA | +30 days |
| 23 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67
Where it was distributed
Nationwide
Questions about this recall
Is Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 1 mg/0.025 mg recalled?
Yes. Teva Pharmaceuticals U recalled Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 1 mg/0.025 mg on 17 Jun 2014. The recall is Class III and its status is Terminated. Recall number D-1439-2014.
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Which lots are affected?
Lot 33805449A, Exp. 12/14
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 U
All 196| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS II | Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
Other Desogestrel recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Viorele, Desogestrel and Ethinyl Estradiol recalledViorele | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS III | Apri (desogestrel and ethinyl estradiol tablets USP) recalledApri | Teva Pharmaceuticals U | Potency & Assay | Nationwide |