Tacrolimus Ointment Recalled for Defective Containers That Split
Glenmark Pharmaceuticals is recalling Tacrolimus Ointment 0.1% because tubes may split at the side seam. The recall affects over 654,000 units distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This FDA Class III recall addresses a container defect only, with no contamination, illnesses, or injuries reported. The hazard is packaging-only in nature, fitting the Low severity category per the rubric for precautionary recalls involving packaging problems.
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
- Affected units
- 654,756
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 (20)
- Lot #s: a) 15200058
- 15200066
- 15200067
- Exp 06/2022
- 15200075
- Exp 07/2022
- 15200094
- Exp 08/2022
- 15200119
- 15200120
- 15200122
- Exp 09/2022
- 15200131
- 15200132
- Exp 10/2022
- 15200133
- 15200134
- 15200136
- 15200139
- Exp 11/2022
UPCs (2)
- 0368462534946
- 0368462881941
Distribution
Distributed nationwide across the United States.
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