CLASS II Drug recall · Reported 4 Jul 2012 · FDA Enforcement Report

Levothroid (levothyroxine sodium tablets, USP), 50 mcg recalled by Lloyd

Lloyd is recalling Levothroid (levothyroxine sodium tablets, USP), 50 mcg, distributed nationwide in the US. The recall was initiated on 3 Feb 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1087589
Quantity recalled19,166 bottles

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-1393-2012
FDA event ID
61094
Recalling firm
Lloyd, Shenandoah, IA
Classification
Class II
Status
Terminated
Recall initiated
3 Feb 2012
FDA classified
22 Jun 2012
Reported
4 Jul 2012
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Potency & Assay

Timeline

3 Feb 2012Recall initiated by company
22 Jun 2012Classified by FDA+140 days
4 Jul 2012Published in enforcement report+12 days

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

Reason for recall

Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Where it was distributed

Nationwide and PR.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.

Which lots are affected?

Lot 1087589

Where was it sold?

Nationwide and PR.

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.

Other products in this recall event

1 other product · FDA event 61094

This product is part of a recall event; the main page for the event is Thyro-Tab 0.050mg recalled by Lloyd.

ReportedClassRecallCompanyReasonWhere
CLASS IIThyro-Tab 0.050mg recalled by LloydLloydPotency & AssayNationwide

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