Recall archive / FDA drug enforcement

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-... — FDA record D-1304-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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.
Reason: Defective Container: Tube split from side seam
Classification: Class III
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Quantity: 654,756 tubes
Agency-reported status: Ongoing
Source record identifier: D-1304-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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.

Label field

Details supplied by the agency

Lot, code or applicability

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.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 10, 2022
Recall initiation date: Jul 11, 2022
Center classification date: Aug 4, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.