The Recall Desk
ModerateFDA (Drugs)·D-013-2013·Announced 2012-10-31

Watson Recalls Zovia Tablets Due to Potential Cross-Contamination

Watson Laboratories is recalling Zovia tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

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, and the hazard involves potential cross-contamination with trace amounts of another drug without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Watson Laboratories, Inc. is recalling specific lots of Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP. The recall was initiated because certain lots of Zovia, along with other products including Lutera, Necon, and Zenchent, could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

The affected product is Zovia Tablets USP, 1 mg/35 mcg, packaged in 28-count dispensers with 6 dispensers per carton. The recall covers 30,267 cartons distributed nationwide and in Puerto Rico. The specific lots affected are 515622AA, 515623AA, and 515623BA, all with an expiration date of 09/30/13.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be discontinued and returned to the distributor or manufacturer for further instructions.

The recalled product

Product
Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.;
Manufacturer
Watson Laboratories Inc
Category
Drug — Oral Contraceptive
Hazard
Affected units
30,267

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 (4)

  • Lot #: 515622AA
  • 515623AA
  • and 515623BA
  • Exp 09/30/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Watson Laboratories Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Watson Laboratories Inc

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Same hazard · cross contamination

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