The Recall Desk
ModerateFDA (Drugs)·D-077-2013·Announced 2012-12-12

Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

Lloyd Inc. of Iowa is recalling specific lots of Levothroid tablets because they failed to meet in-process specification requirements.

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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to manufacturing specifications rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Lloyd Inc. of Iowa is recalling 31,252 bottles of Levothroid (levothyroxine sodium tablets, USP), 88 mcg, 100-count. The recall involves Lot #1096369 (exp. 11/30/2012) and Lot #1092046 (exp. 7/31/2012). The product was manufactured for Forest Pharmaceuticals, Inc., a subsidiary of Forest Laboratories, Inc., by Lloyd Pharmaceutical in Shenandoah, Iowa.

The recall was initiated because the product experienced cGMP (Current Good Manufacturing Practice) deviations and did not meet in-process specification requirements. The agency has classified this as a Class II recall.

Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on replacement medication.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Prescription Medication
Hazard

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 (4)

  • Lot #1096369
  • exp. 11/30/2012
  • and #1092046
  • exp. 7/31/2012

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 12 recalled by Lloyd Inc. of Iowa 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 12 products in this recall →

Related recalls

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Same hazard · manufacturing deviation

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