The Recall Desk
ModerateFDA (Drugs)·D-1397-2012·Announced 2012-07-04

Teva Recalls Zeosa Oral Contraceptive Tablets Due to Impurity Concerns

Teva Pharmaceuticals is recalling specific lots of Zeosa chewable oral contraceptive tablets because they may not meet impurity specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is described as a potential failure to meet impurity specifications rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 100,761 cartons of Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg). The affected product is distributed nationwide and includes NDC 0093-2090-28 and 0093-2090-58.

The recall is being conducted due to the potential for some lots not meeting impurity specifications. The specific lots affected are 33800226A (Exp 7/2012), 33800333A (Exp 10/2012), 33800870A (Exp 10/2012), 33802533A (Exp 4/2013), and 33802720A (Exp 8/2013).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or healthcare provider for replacement or refund.

The recalled product

Product
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons contai
Affected units
100,761

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot #'s 33800226A
  • Exp 7/2012
  • 33800333A
  • Exp 10/2012
  • 33800870A
  • 33802533A
  • Exp 4/2013
  • and 33802720A
  • Exp 8/2013

Distribution

Distributed nationwide across the United States.