The Recall Desk
SevereFDA (Drugs)·D-451-2013·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 stability failures. The recall covers specific lots distributed nationwide and to Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential quality failures that may affect drug efficacy or safety.

Plain-English summary

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. The product was manufactured for Forest Pharmaceuticals, Inc. The recall is being conducted 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 affected product includes Lot #1095923 (Expiration May-13) and Lot #1097828 (Expiration Jul-13). The firm distributed the bulk product 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 recalled product and contact their healthcare provider for a replacement or alternative treatment. The recall is classified as FDA Class II.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Prescription Medication
Hazard
Affected units
29,489

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 #: 1095923
  • Exp May-13
  • 1097828
  • 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 →

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