The Recall Desk
ModerateFDA (Drugs)·D-432-2013·Announced 2013-05-29

Lloyd Inc. Recalls Levothroid Tablets Due to Stability Failures

Lloyd Inc. of Iowa is recalling 4,440 bottles of Levothroid 50 mcg tablets due to cGMP deviations and stability failures in previous lots.

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 involves a temporary or medically reversible adverse health consequence. The source cites cGMP deviations and stability failures without reporting specific injuries or illnesses, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Lloyd Inc. of Iowa is recalling 4,440 bottles of Levothroid (levothyroxine sodium tablets, USP) 50 mcg, NDC 0456-1321-01. The product was manufactured for Forest Pharmaceuticals, Inc. The specific lot number is 1098751, with an expiration date of March 2013.

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 and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Thyroid Hormone
Hazard
Affected units
4,440

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 #: 1098751
  • Exp. Mar-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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