Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

Class I - Dangerous

💊 Drugs Recalled: July 11, 2022 Glenmark Pharmaceuticals Inc., USA Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
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; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 15210094, 15210097, 15210099, Exp 03/2023; 15210100, 15210101, 15210104, Exp 04/2023; 15210122, Exp 05/2023; 15210148, 15210149, 15210153, 15210155, 15210157, 15210158, Exp 06/2023; 15210173, 15210174, 15210176, 15210177, 15210178, 15210179, Exp 07/2023; 15210184, 15210186, Exp 08/2023; 15210214, Exp 09/2023; 15210225, 15210226, 15210228, 15210230, 15210231, Exp 10/2023; 15220001, 15220002, Exp 12/2023. b) 15200092, Exp 08/2022; 15200114, 15200115, Exp 09/2022; 15200123, 15200124, Exp 10/2022; 15200142, 15200144, Exp 11/2022; 15210014, 15210015, 15210021, Exp 12/2022; 15210031, Exp 01/2023; 15210055, Exp 02/2023; 15210073, 15210075, Exp 03/2023; 15210117, 15210118, Exp 04/2023; 15210144, 15210147, 15210160, 15210162, Exp 06/2023; 15210171, Exp 07/2023; 15210187, 15210190, 15210191, 15210193, Exp 08/2023; 15210212, Exp 09/2023; 15210244, 15210247, Exp 11/2023; 15220007, Exp 12/2023; 15220019, 15220028, Exp 01/2024; 15220032, 15220034, 15220053, Exp 02/2024; 15220062, 15220064, 15220072, Exp 03/2024. c) 15200065, Exp 06/2022; 15200108, 15200109, Exp 09/2022; 15200125, Exp 10/2022; 15200148, 15200149, 15200150, Exp 11/2022; 15210007, 15210009, 15210012, 15210018, Exp 12/2022; 15210049, Exp 02/2023; 15210076, 15210077, 15210089, Exp 03/2023; 15210112, 15210114, Exp 04/2023; 15210124, 15210125, 15210127, Exp 05/2023; 15210169, 15210170, Exp 07/2023; 15210196, 15210199, Exp 08/2023; 15210204, 15210206, 15210207, 15210210, Exp 09/2023; 15210248, Exp 11/2023; 15220004, 15220013, 15220014, 15220015, Exp 12/2023; 15220025, 15220026, Exp 01/2024.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Glenmark Pharmaceuticals Inc., USA
Reason for Recall:: Defective Container: Tube split from side seam
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

Product Codes/Lot Numbers:

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; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 15210094, 15210097, 15210099, Exp 03/2023; 15210100, 15210101, 15210104, Exp 04/2023; 15210122, Exp 05/2023; 15210148, 15210149, 15210153, 15210155, 15210157, 15210158, Exp 06/2023; 15210173, 15210174, 15210176, 15210177, 15210178, 15210179, Exp 07/2023; 15210184, 15210186, Exp 08/2023; 15210214, Exp 09/2023; 15210225, 15210226, 15210228, 15210230, 15210231, Exp 10/2023; 15220001, 15220002, Exp 12/2023. b) 15200092, Exp 08/2022; 15200114, 15200115, Exp 09/2022; 15200123, 15200124, Exp 10/2022; 15200142, 15200144, Exp 11/2022; 15210014, 15210015, 15210021, Exp 12/2022; 15210031, Exp 01/2023; 15210055, Exp 02/2023; 15210073, 15210075, Exp 03/2023; 15210117, 15210118, Exp 04/2023; 15210144, 15210147, 15210160, 15210162, Exp 06/2023; 15210171, Exp 07/2023; 15210187, 15210190, 15210191, 15210193, Exp 08/2023; 15210212, Exp 09/2023; 15210244, 15210247, Exp 11/2023; 15220007, Exp 12/2023; 15220019, 15220028, Exp 01/2024; 15220032, 15220034, 15220053, Exp 02/2024; 15220062, 15220064, 15220072, Exp 03/2024. c) 15200065, Exp 06/2022; 15200108, 15200109, Exp 09/2022; 15200125, Exp 10/2022; 15200148, 15200149, 15200150, Exp 11/2022; 15210007, 15210009, 15210012, 15210018, Exp 12/2022; 15210049, Exp 02/2023; 15210076, 15210077, 15210089, Exp 03/2023; 15210112, 15210114, Exp 04/2023; 15210124, 15210125, 15210127, Exp 05/2023; 15210169, 15210170, Exp 07/2023; 15210196, 15210199, Exp 08/2023; 15210204, 15210206, 15210207, 15210210, Exp 09/2023; 15210248, Exp 11/2023; 15220004, 15220013, 15220014, 15220015, Exp 12/2023; 15220025, 15220026, Exp 01/2024.