CLASS II Drug recall · Reported 16 Oct 2013 · FDA Enforcement Report

Next Choice" One Dose Emergency Contraceptive recalled

Watson Laboratories is recalling Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg/Blister, distributed nationwide in the US. The recall was initiated on 23 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: 580974AA and 580975AA. Exp: 09/14
Quantity recalled1,002,394 tablets

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-66360-001
FDA event ID
66360
Recalling firm
Watson Laboratories, Corona, CA
Classification
Class II
Status
Terminated
Recall initiated
23 Sep 2013
FDA classified
9 Oct 2013
Reported
16 Oct 2013
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

23 Sep 2013Recall initiated by company
9 Oct 2013Classified by FDA+16 days
16 Oct 2013Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Product as listed by the FDA

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.

Where it was distributed

US. No international. NATIONWIDE

Nationwide

Questions about this recall

Why was it recalled?

Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Which lots are affected?

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

Where was it sold?

US. No international. NATIONWIDE

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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