Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets Recalled by Teva Pharmaceuticals USA, Inc. Due to Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene...

Date: March 15, 2013
Company: Teva Pharmaceuticals USA, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA, Inc. directly.

Affected Products

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

Quantity: 47,200 blister packs

Why Was This Recalled?

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report