The Recall Desk
ModerateFDA (Drugs)·D-075-2013·Announced 2012-12-12

Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

Lloyd Inc. of Iowa is recalling specific bottles of Levothroid tablets because they failed to meet in-process specification requirements during manufacturing.

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 without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Lloyd Inc. of Iowa is recalling 13,692 bottles of Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles. The affected product is identified by Lot #1097830 with an expiration date of 1/31/2013. The recall was initiated because the product did not meet in-process specification requirements and involved cGMP deviations.

The distribution of the recalled product was nationwide, including Puerto Rico. There was no foreign, military, or government distribution. The product was manufactured for Forest Pharmaceuticals, Inc., a subsidiary of Forest Laboratories, Inc., by Lloyd Pharmaceutical in Shenandoah, IA.

Consumers who have this specific lot of Levothroid should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication. The recall is classified as FDA Class II.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Prescription Medication
Hazard

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 (1)

  • Lot #1097830 exp. 1/31/2013

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 12 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 12 products in this recall →

Related recalls

Same manufacturer · Lloyd Inc. of Iowa

See all →

Same hazard · cGMP deviation

See all →