The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1294-2019·Announced 2019-05-29

Mallinckrodt Recalls Amitiza Capsules Due to Labeling Mix-Up

Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules because 8 mcg and 24 mcg bottles were found with incorrect contents.

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. The hazard is a labeling mix-up involving dosage strength, which is a significant error but does not involve a high-risk pathogen or immediate structural defect.

Plain-English summary

Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules due to a labeling mix-up. The recall involves 89,808 bottles of Amitiza 8 mcg capsules, NDC 64764-080-60, Lot # 3229691-61, Exp 01/2022. The recall was initiated because 24 mcg capsules were found in a bottle labeled as 8 mcg.

Additionally, Amitiza 24 mcg capsules are being recalled because a sealed 60-count bottle was found to contain only 8 mcg capsules. The FDA classifies this incident as a labeling mix-up issue. The affected products were distributed nationwide in the United States.

Consumers should check their medication bottles for the specific lot number and expiration date listed above. If the product matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
AMITIZA (LUBIPROSTONE)
Brand
AMITIZA
Manufacturer
MALLINCKRODT PHARMACEUTICALS
Category
Drug — Prescription Medication
Hazard
Affected units
89,808

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 (2)

  • Lot #: 3229691-61
  • Exp 01/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by MALLINCKRODT PHARMACEUTICALS 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 →

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