The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-083-2013·Announced 2012-12-12

Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 agency classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to manufacturing specifications rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Lloyd Inc. of Iowa is recalling 36,978 bottles of Levothroid (levothyroxine sodium tablets, USP), 137 mcg, 100-count. The recall involves Lot #1095212 (exp. 4/30/2013) and Lot #1088877 (exp. 11/30/2012). The product is manufactured for Forest Pharmaceuticals, Inc.

The recall was initiated because the product does not meet in-process specification requirements and involves cGMP (Current Good Manufacturing Practice) deviations. 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 should stop using the affected lots and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, 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 (3)

  • Lot #1095212 exp. 4/30/2013
  • and #1088877
  • exp. 11/30/2012

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 →

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