The Recall Desk
ModerateFDA (Drugs)·D-448-2013·Announced 2013-05-29

Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets due to cGMP deviations and insufficient stability data.

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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source cites cGMP deviations and insufficient stability data without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Lloyd Inc. of Iowa is recalling 12,911 bottles of Levothroid (levothyroxine sodium tablets, USP), 137 mcg, NDC 0456-1331-01. The product was manufactured by Lloyd Pharmaceutical in Shenandoah, IA, for Forest Pharmaceuticals, Inc. in St. Louis, MO.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Following a quality review of stability failures in previous lots, the firm determined there is insufficient data to confirm that other lots are not affected.

The bulk product was distributed to Forest Laboratories, Inc., which repackaged it into 100-tablet bottles. Distribution was made to 75 customers nationwide and in Puerto Rico. The affected lot number is 1096372, with an expiration date of May-13. Consumers should contact their healthcare provider or pharmacist for guidance on this prescription medication.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01.
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Thyroid Hormone
Hazard
Affected units
12,911

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 (2)

  • Lot #: 1096372
  • Exp May-13.

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 20 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 20 products in this recall →

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Same hazard · cGMP deviation

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