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SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC Recalls

All product recalls associated with SUN PHARMACEUTICAL INDUSTRIES INC.

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

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 1021–1040 of 4747 recalls

Chlorthalidone Tablets (Sun Pharma) – Foreign Matter Contamination (2022)

Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

Class IIModerate

FDAFeb 7, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Vista Magnesium Flex reagent cartridge ...

Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.

FDAJan 28, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software...

1...50 515253 54...238

Page 52 of 238Next

Distribution of Defibrillators that are not approved or cleared for distribution US Market.

FDAJan 28, 2022Nationwide• Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

Over-the-Counter Drugs (Geri-Care) – Packaging Issue (2022)

This recall involves bottles of Geri-Care Brand over-the-counter acetaminophen and aspirin. The acetaminophen is 500mg with 1,000 tablets in the bottle. The aspirin was sold in 81mg with 300 and 1,000 tablets in the bottle and 325mg with 250 and 1,000 tablets in the bottle. Product Count Extra Strength Acetaminophen 500mg Tablets 1,000 Regular Strength Enteric Coated Aspirin 325mg Tablets 250 Regular Strength Enteric Coated Aspirin 325mg Tablets 1,000 Adult Low Dose Enteric Coated Aspirin 81mg Tablets 300 Adult Low Dose Enteric Coated Aspirin 81mg Tablets 1,000

CPSCJan 26, 2022Nationwide• Geri-Care Pharmaceuticals, of Brooklyn, New York

Proctofoam HC (Mylan) – cGMP Deficiencies (2022)

cGMP deficiencies

Class IIModerate

FDAJan 21, 2022Nationwide• Mylan Pharmaceuticals Inc

SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel: The Sight OLO device is a computer vision based platform ...

In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

FDAJan 20, 2022Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

Doxylamine Pyridoxine Tablets (Teva) – Dissolution Failure (2022)

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

Class IIModerate

FDAJan 18, 2022Nationwide• Teva Pharmaceuticals USA

BASE 10 GENETICS INC: RNAstill Molecular Transport Medium Vial, Catalog number ...

The product does not have 510(k) clearance.

FDAJan 10, 2022Nationwide• BASE 10 GENETICS INC

Clobetasol Propionate Foam (Ingenus) – CGMP Issues (2022)

CGMP Deviations

Class IIModerate

FDAJan 10, 2022Nationwide• Ingenus Pharmaceuticals Llc

Tretinoin Capsules (Teva) – Dissolution Failure (2022)

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.

Class IIModerate

FDAJan 10, 2022Nationwide• Teva Pharmaceuticals USA

Mimvey Tablets (Teva) – Mislabeling (2022)

Mislabeling

Class IIILow

FDAJan 7, 2022Nationwide• Teva Pharmaceuticals USA

Mimvey Tablets (Teva) – Mislabeling (2022)

Mislabeling

Class IIILow

FDAJan 7, 2022Nationwide• Teva Pharmaceuticals USA

Semglee Insulin (Mylan) – Missing Label (2022)

Labeling: Missing Label: label missing from some Semglee prefilled pens.

Class IHigh

FDAJan 5, 2022Nationwide• Mylan Pharmaceuticals Inc

MethylPREDNISolone Acetate (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 31, 2021MS, OH, TN• Teva Pharmaceuticals USA

Norepinephrine Bitartrate (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 31, 2021MS, OH, TN• Teva Pharmaceuticals USA

Oxycodone Tablets (Lupin) – Impurity Test Failure (2021)

Out-of-specification impurity test result observed at 18-month long term stability time point.

Class IIILow

FDADec 29, 2021IN, NY, OH• Lupin Pharmaceuticals Inc.

Metformin Extended Tablets (VIONA) – NDMA Excess (2021)

CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDADec 27, 2021Nationwide• VIONA PHARMACEUTICALS INC

Empowered Diagnostics LLC: ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

FDADec 22, 2021Nationwide• Empowered Diagnostics LLC

Pearl River Propane Hoses (Flame King) - fire hazard (2021)

Fire/Burn Risk

This recall involves Pearl River 3Q20 or 4Q20 propane hoses used in propane powered torches and other propane accessories. Hoses included in the recall are: PEARL RIVER FILE NO. 70177655 LP-GAS HOSE HP14 M.W.P 350 PSIG 1/4" STANDARD CSA8.3&UL21 3Q20 T/P PEARL RIVER FILE NO. 70177655 LP-GAS HOSE HP14 M.W.P 350 PSIG 1/4" STANDARD CSA8.3&UL21 4Q20 T/P The item/batch number is printed on the body of the propane hose and includes the following: Item # Item Description and Brand Name YSNPQ5000T YSNPQ5000Ta Flame King 500,000 BTU Weed Burner Torch YSNAX1-061 YSNAX1-061a Flame King 320,000 BTU Propane Torch Kit YSNAX1-078 YSNAX1-078a Flame King 340,000 BTU Propane Torch Kit with Ignitor ALGA09 Flame King 4 ft QCC1 Propane Adapter Hose to 1 lb Appliance

CPSCDec 22, 2021Nationwide• Guangzhou Pearl River Plastic Hose Co. Ltd, of China (hoses)

Gatifloxacin Ophthalmic Solution (Lupin) – Stability Failure (2021)

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

Class IIILow

FDADec 22, 2021Nationwide• Lupin Pharmaceuticals Inc.