The Recall Desk
ModerateFDA (Drugs)·D-434-2013·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 and involves cGMP deviations and stability data concerns without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium tablets, USP), 75 mcg, 100 tablets per bottle. The product was manufactured for Forest Pharmaceuticals, Inc. The recall involves 19,787 bottles with Lot # 1098752 (Exp. Mar-13) and Lot # 1099890 (Exp. Apr-13).

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. Consumers should contact their healthcare provider or pharmacist for instructions on how to manage the recall.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Thyroid Hormone
Hazard
Affected units
19,787

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 #: 1098752
  • Exp. Mar-13
  • 1099890
  • Exp Apr-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

Same manufacturer · Lloyd Inc. of Iowa

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Same hazard · cGMP deviation

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