Agency classClass IIOur severity:Moderate FDA (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).

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Watson Laboratories Inc
Category: Drug — Oral Contraceptive
Hazard: cross-contamination
foreign-substance
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 →

Same manufacturer · Watson Laboratories Inc

See all →

Moderate
Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Broken Tablets
FDA (Drugs) · 2014-02-05
Severe
Watson Recalls Carisoprodol Tablets Due to Metal Particulates
FDA (Drugs) · 2014-01-15
Moderate
Watson Recalls Next Choice Emergency Contraceptive Tablets Due to Breakage
FDA (Drugs) · 2013-10-16
Severe
Watson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination
FDA (Drugs) · 2013-10-09
Low
Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Defective Seals
FDA (Drugs) · 2013-09-25

Same hazard · cross contamination