The Recall Desk
ModerateFDA (Drugs)·D-015-2013·Announced 2012-10-31

Watson Recalls Zenchent Tablets Due to Potential Hydrochlorothiazide Contamination

Watson Laboratories is recalling Zenchent tablets because certain lots may be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

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, but the source text describes the hazard as 'potentially' contaminated with 'trace amounts' and does not report any illnesses or injuries, fitting the criteria for a voluntary precautionary recall or low-risk contamination.

Plain-English summary

Watson Laboratories, Inc. is recalling Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg. The recall involves 12,333 cartons of the medication, which are packaged as 28-count tablets per dispenser with 6 dispensers per carton. The affected product is identified by Lot # 514767AA with an expiration date of 03/31/14.

The recall was initiated because certain lots of Zenchent, along with Zovia, Lutera, and Necon, could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination with other products. The affected units were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product
Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 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., Corona, CA 928
Manufacturer
Watson Laboratories Inc
Category
Drug — Oral Contraceptive
Hazard
Affected units
12,333

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 (2)

  • Lot #: 514767AA
  • Exp 03/31/14

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 →

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Same manufacturer · Watson Laboratories Inc

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Same hazard · cross contamination

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