The Recall Desk
ModerateFDA (Drugs)·D-447-2013·Announced 2013-05-29

Lloyd Inc. Recalls Levothroid Tablets Due to Quality 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, and the source text cites cGMP deviations and insufficient stability data without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium tablets, USP), 125 mcg, 100 tablets per bottle. The product was manufactured for Forest Pharmaceuticals, Inc. The recall involves 77,471 bottles distributed to 75 customers nationwide and in Puerto Rico.

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.

Affected lots include 1095209, 1095211 (Exp Apr-13), and 1097408, 1097731, 1097732 (Exp Jul-13). Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for instructions on return or replacement.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Thyroid Hormone
Hazard
Affected units
77,471

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 (7)

  • Lot #: 1095209
  • 1095211
  • Exp Apr-13
  • 1097408
  • 1097731
  • 1097732
  • Exp Jul-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 →

Related recalls

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Same hazard · quality deviation

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