Food, drugs, devices › Teva Pharmaceuticals USA, Inc.
Drug recall: Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratorie
FDA enforcement event 64644 is a drug recall by Teva Pharmaceuticals USA, Inc. of Sellersville, PA, initiated 15 Mar 2013 and classified Class III, with 4 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 26% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 10 Apr 2014. Initiation: voluntary: firm initiated. Teva Pharmaceuticals USA, Inc. has 60 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teva Pharmaceuticals USA, Inc., Sellersville, PA.
Reason for recall
"Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing"
Distribution
"Nationwide distribution. No foreign or government accounts."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-681-2013 | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67 | 148,785 blister packs | Class III | Terminated | 17 Jul 2013 |
| D-682-2013 | Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58 | 47,200 blister packs | Class III | Terminated | 17 Jul 2013 |
| D-683-2013 | Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66 | 54,412 blister packs | Class III | Terminated | 17 Jul 2013 |
| D-684-2013 | 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 | 36,708 blister packs | Class III | Terminated | 17 Jul 2013 |
Context
Other enforcement events for Teva Pharmaceuticals USA, Inc.
All 60 events for Teva Pharmaceuticals USA, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide distribution. No foreign or government accounts."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.