The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1393-2012·Announced 2012-07-04

Lloyd Inc Recalls Subpotent Levothroid Levothyroxine Sodium Tablets

Lloyd Inc is recalling 19,166 bottles of Levothroid 50 mcg tablets because they failed potency testing at 9 months.

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 corresponds to a Moderate severity score when no specific hospitalizations or severe injuries are reported in the source text.

Plain-English summary

Lloyd Inc is recalling 19,166 bottles of Levothroid (levothyroxine sodium tablets, USP), 50 mcg, packaged in 100-count bottles. The product is identified by NDC 0456-1321-01 and Lot 1087589. The recall was initiated because the tablets were found to be subpotent, meaning they had a low assay result at the 9-month test interval.

The affected product was distributed nationwide and in Puerto Rico. Levothroid is a prescription medication manufactured for Forest Pharmaceuticals, Inc., a subsidiary of Forest Laboratories, Inc., by Lloyd Pharmaceutical in Shenandoah, Iowa.

Consumers with this specific lot of Levothroid should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, 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
Affected units
19,166

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 1087589

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Lloyd Inc 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 2 products in this recall →

Same manufacturer · Lloyd Inc

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