The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-449-2013·Announced 2013-05-29

Lloyd Inc. Recalls Levothroid Tablets Due to Stability Failures

Lloyd Inc. of Iowa is recalling specific lots of Levothroid tablets due to stability failures and insufficient data to rule out other affected 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, which typically involves a temporary or medically reversible adverse health consequence. The source cites cGMP deviations and stability failures without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium tablets, USP), 150 mcg, 100 tablets per bottle. The product was manufactured for Forest Pharmaceuticals, Inc. The recall involves 61,347 bottles distributed to 75 customers nationwide and in Puerto Rico.

The recall was initiated due to current good manufacturing practice (cGMP) deviations and stability failures identified in previous lots. Following a quality review, the firm determined there is insufficient data to confirm that other lots are not affected. The affected lots include 1095213, 1095214, 1097733, and 1098540, with expiration dates ranging from April 2013 to August 2013.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative medication options if they are currently using the recalled product.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01.
Manufacturer
Lloyd Inc. of Iowa
Category
Drug — Prescription Medication
Hazard
Affected units
61,347

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 (7)

  • Lot #: 1095213
  • 1095214
  • Exp Apr-13
  • 1097733
  • Exp Jul-13
  • 1098540
  • Exp Aug-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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