CLASS III Drug recall · Reported 23 Jul 2014 · FDA Enforcement Report
Velivet (desogestrel and ethinyl estradiol tablets recalled
Teva Pharmaceuticals USA is recalling Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 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 USA, 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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 68610| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Apri (desogestrel and ethinyl estradiol tablets USP) recalledApri | Teva Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS III | Kariva (desogestrel/ethinyl estradiol recalled by Teva Pharmaceuticals UKariva | Teva Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS III | Mircette (desogestrel/ethinyl estradiol recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Desogestrel recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Viorele, Desogestrel and Ethinyl Estradiol recalledViorele | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Kariva (desogestrel/ethinyl estradiol recalled by Teva Pharmaceuticals UKariva | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Apri (desogestrel and ethinyl estradiol tablets USP) recalledApri | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |