The Recall Desk
ModerateFDA (Drugs)·D-079-2013·Announced 2012-12-12

Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements due to cGMP deviations.

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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text cites cGMP deviations and failure to meet in-process specifications without reporting specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium tablets, USP), 112 mcg, 100-count bottles. The recall affects 37,827 bottles with NDC 0456-1330-01. The specific lots involved are #1096371 (exp. 5/31/2013) and #1092299 (exp. 1/31/2013).

The recall was initiated because the product does not meet in-process specification requirements due to Current Good Manufacturing Practice (cGMP) deviations. The source text does not specify the exact nature of the deviations or the specific in-process specifications that were not met.

Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement medication.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, 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 (4)

  • Lot #1096371
  • exp. 5/312013
  • and #1092299
  • 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

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Same hazard · cGMP deviation

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