Tacrolimus Ointment Recalled for Defective Containers That Split

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Tacrolimus Ointment 0.1% for topical dermatological use due to a container defect where tubes may split along the side seam. The recall affects 654,756 units across three package sizes (30 g, 60 g, and 100 g) distributed nationwide throughout the United States.

A split tube could allow medication to leak out or compromise the product's integrity. No illnesses or injuries have been reported in connection with this defect. The FDA has classified this as a Class III recall.

Patients using an affected product should check their medication's lot number against the list of affected lots provided by the FDA. If your product matches an affected lot (ranging from expiration dates of June 2022 through February 2024), stop using it and contact your pharmacist or healthcare provider for a replacement.

The lot numbers and expiration dates are available in the FDA's official recall notice. Consumers should contact their pharmacy if they have questions about whether their product is affected.

The recalled product

Product

TACROLIMUS (TACROLIMUS)

Brand

TACROLIMUS

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Category

Drug — Topical / Dermatological

Hazard

• defective-container
• tube-split

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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