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Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited Recalls

All product recalls associated with Alembic Pharmaceuticals Limited.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 881–900 of 21319 recalls

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

High

FDAMay 7, 2025Nationwide• Medtronic MiniMed, Inc.

HardyCHROM CRE (Hardy Diagnostics) – Quality Control Failure (2025)

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

Low

FDA

1...43 444546 47...1066

Page 45 of 1066Next

May 6, 2025

AZ, CA, CO +19 more

• Hardy Diagnostics

Powered Laser Surgical Instrument (Olympus) – Thermal Incident Risk (2025)

Fire/Burn Risk

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

High

FDAMay 6, 2025Nationwide• Olympus Corporation of the Americas

Apple & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

Frozen Shrimp (Chicken of the Sea) – Undeclared Sulfites (2025)

Undeclared Allergen

Frozen Raw Peeled & Deveined tail on, shrimp contains undeclared sulfites

Class IHigh

FDAMay 6, 2025CO, IN• TRI-UNION FROZEN PRODUCTS INC DBA CHICKEN OF THE SEA FROZEN FOOD

Celery & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

EVIS EXERA III Duodenovideoscope (Olympus) – Contamination Risk (2025)

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

Moderate

FDAMay 5, 2025Nationwide• Olympus Corporation of the Americas

LifeShield Infusion Software (ICU Medical) – Drug Library Defects (2025)

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

High

FDAMay 2, 2025Nationwide• ICU Medical, Inc.

Testosterone Cypionate Injection (Empower Pharmacy) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2025Nationwide• Empower Clinic Services, LLC dba Empower Pharmacy

Kids Multivitamin Gummies (Nordic Naturals) – Mislabeled Product (2025)

Product is mislabeled.

Class IIILow

FDAMay 2, 2025AK, AZ, CA +17 more• Nordic Naturals, Inc.

Canturio Smart Extension (Canary Medical) – Labeling Error (2025)

Due to labeling error. Product incorrectly labeled.

Low

FDAMay 2, 2025IN• Canary Medical, Inc.

BX2 Needle Guide (Civco) – Probe Packaging Breach (2025)

During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

Moderate

FDAMay 1, 2025GA• Civco Medical Instruments Co. Inc.

BioFire Respiratory Panel (BioFire) – Test Result Errors (2025)

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Moderate

FDAApr 30, 2025IN• BioFire Diagnostics, LLC