CLASS III Drug recall · Reported 17 Apr 2013 · FDA Enforcement Report
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 15 mg/0 recalled
Teva Pharmaceuticals USA is recalling Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 15 mg/0, distributed nationwide in the US. The recall was initiated on 12 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-246-2013
- FDA event ID
- 64607
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Jolessa
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Mar 2013
- FDA classified
- 10 Apr 2013
- Reported
- 17 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 12 Mar 2013 | Recall initiated by company | |
| 10 Apr 2013 | Classified by FDA | +29 days |
| 17 Apr 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
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
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Where it was distributed
Nationwide
Questions about this recall
Is Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 15 mg/0 recalled?
Yes. Teva Pharmaceuticals USA recalled Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 15 mg/0 on 12 Mar 2013. The recall is Class III and its status is Terminated. Recall number D-246-2013.
Why was it recalled?
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Which lots are affected?
Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
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.
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Other Levonorgestrel / Ethinyl Estradiol recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Jolessa(R) (levonorgestrel/ethinyl estradiol tablets recalledJolessa | Teva Pharmaceuticals USA | Benzene | Nationwide |
| Drug | CLASS III | Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets) recalledCamrese | Teva Pharmaceuticals USA | Benzene | Nationwide |
| Drug | CLASS III | Jolessa (levonorgestrel/ethinyl estradiol tablets recalledJolessa | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |