The Recall Desk
ModerateFDA (Drugs)·D-436-2013·Announced 2013-05-29

Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

Lloyd Inc. of Iowa is recalling Levothroid tablets due to cGMP deviations and insufficient stability data. The recall affects 12,156 bottles distributed nationwide and to Puerto Rico.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical based on cGMP deviations and insufficient stability data, fitting the criteria for a moderate severity score.

Plain-English summary

Lloyd Inc. of Iowa is recalling 12,156 bottles of Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only. The product was manufactured for Forest Pharmaceuticals, Inc., and repackaged by Forest Laboratories, Inc. The recall is due to current Good Manufacturing Practice (cGMP) deviations and insufficient data to determine that other lots are not affected following stability failures in previous lots.

The affected product is identified by Lot # 1098967 and has an expiration date of Mar-13. The product was distributed to 75 customers nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Thyroid Hormone
Hazard
Affected units
12,156

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 #: 1098967
  • 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 →

Related recalls

Same manufacturer · Lloyd Inc. of Iowa

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Same hazard · cGMP deviation

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