The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-085-2013·Announced 2012-12-12

Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

Lloyd Inc. of Iowa is recalling 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 recall is classified as FDA Class II. The hazard is a cGMP deviation and failure to meet in-process specifications, which is a quality control issue without reported specific injuries or illnesses, fitting the Moderate severity criteria for low-risk or precautionary recalls.

Plain-English summary

Lloyd Inc. of Iowa is recalling 1,443 bottles of Levothroid (levothyroxine sodium tablets, USP), 300 mcg, 100-count bottles. The product is prescription-only and was manufactured for Forest Pharmaceuticals, Inc. The specific lot affected is #1097178, with an expiration date of 7/31/2013.

The recall was initiated because the product experienced cGMP (Current Good Manufacturing Practice) deviations and does not meet in-process specification requirements. This indicates a failure in the manufacturing quality control process rather than a specific contamination or labeling error.

Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, 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 — Thyroid Hormone
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 (1)

  • Lot #1097178 exp. 7/31/2013

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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