The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-450-2013·Announced 2013-05-29

Lloyd Inc. Recalls Levothroid Tablets Due to Stability Failures

Lloyd Inc. of Iowa is recalling Levothroid tablets due to cGMP deviations and stability failures in previous lots.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 based on quality control deviations and insufficient stability data rather than confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium tablets, USP), 175 mcg, 100 tablets per bottle. The recall involves 32,345 bottles of the product, which was manufactured for Forest Pharmaceuticals, Inc. The specific lots affected are 1095922 (Exp May-13), 1097735 (Exp Jul-13), and 1099892 (Exp Oct-13).

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Following a quality review of stability failures found 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 check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Thyroid Hormone
Hazard
Affected units
32,345

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 (6)

  • Lot #r: 1095922
  • Exp May-13
  • 1097735
  • Exp Jul-13
  • 1099892
  • Exp Oct-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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