The Recall Desk
ModerateFDA (Drugs)·D-014-2013·Announced 2012-10-31

Watson Recalls Lutera Tablets Due to Potential Hydrochlorothiazide Contamination

Watson Laboratories is recalling specific lots of Lutera tablets because they may contain 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, and the hazard involves potential trace contamination with an unrelated medication (HCTZ) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Watson Laboratories, Inc. is recalling specific lots of Lutera (levonorgestrel and ethinyl estradiol) Tablets USP. The recall involves 67,860 cartons of the medication, which are packaged as 28-count tablets per dispenser with 6 dispensers per carton. The affected lots were distributed nationwide and in Puerto Rico.

The recall was initiated because certain lots of Lutera, along with related products Zovia, Necon, and Zenchent, could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination with other products. The specific lot numbers affected are 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, and 517923AB, all with an expiration date of 03/31/14.

Consumers and healthcare providers should check their medication packaging for these specific lot numbers. If the medication matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, 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., Pa
Manufacturer
Watson Laboratories Inc
Category
Drug — Oral Contraceptive
Hazard
Affected units
67,860

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 (7)

  • Lot #: 517921AA
  • 517921AB
  • 517922AA
  • 517922AB
  • 517923AA
  • 517923AB
  • 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 →

Related recalls

Same manufacturer · Watson Laboratories Inc

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Same hazard · cross contamination

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