The Recall Desk
ModerateFDA (Drugs)·D-66360-001·Announced 2013-10-16

Watson Recalls Next Choice Emergency Contraceptive Tablets Due to Breakage

Watson Laboratories is recalling Next Choice emergency contraceptive tablets because they may break when pushed through the packaging.

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 defect involves physical breakage of the tablet during packaging removal, which is a moderate risk of harm without reported injuries.

Plain-English summary

Watson Laboratories Inc is recalling Next Choice One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54). The recall involves approximately 1,002,394 tablets distributed nationwide in the United States.

The recall was initiated due to multiple complaints regarding push-through tablet breakage. This defect means the tablets may break when users attempt to push them through the blister card packaging.

Consumers with this product should stop using it and contact Watson Laboratories or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.
Manufacturer
Watson Laboratories Inc
Category
Drug — Emergency Contraceptive
Hazard
Affected units
1,002,394

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 (1)

  • Lot#: 580974AA and 580975AA. Exp: 09/14

Distribution

Distributed nationwide across the United States.

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