The Recall Desk
ModerateFDA (Drugs)·D-0417-2021·Announced 2021-06-02

Cardinal Health Recalls Linzess Capsules Due to Temperature Excursions

Cardinal Health is recalling 1,529 bottles of Linzess (linaclotide) capsules due to intermittent exposure to temperature excursions during storage.

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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving potential but unconfirmed risk.

Plain-English summary

Cardinal Health Inc. is recalling 1,529 bottles of Linzess (linaclotide) capsules, 72 mcg, 30-count bottles. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product is distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is W04411. The product is distributed by Allergan USA, Inc.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. 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
LINZESS (LINACLOTIDE)
Brand
LINZESS
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
1,529

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)

  • W04411

UPCs (3)

  • 0304561203307
  • 0304561202300
  • 0304561201303

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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