CLASS III Drug recall · Reported 27 Jun 2012 · FDA Enforcement Report
Jolessa (levonorgestrel/ethinyl estradiol tablets recalled
Teva Pharmaceuticals USA is recalling Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser, distributed nationwide in the US. The recall was initiated on 23 Apr 2012 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-1384-2012
- FDA event ID
- 61759
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Apr 2012
- FDA classified
- 19 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 23 Apr 2012 | Recall initiated by company | |
| 19 Jun 2012 | Classified by FDA | +57 days |
| 27 Jun 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, 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
Why was it recalled?
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Which lots are affected?
Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
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.
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Other Jolessa (levonorgestrel recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0 recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |