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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

20

Past Year

13

Class I (Serious)

0

Most Recent

Oct 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 1–20 of 20 recalls

Lisdexamfetamine 70mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine 20mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine 60mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine 40mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine 10mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine 30mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine 50mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Technetium Tc 99m Mertiatide Kit (Sun Pharmaceutical) – dissolution specification failure (2025)

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

Class IIModerate

FDASep 3, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Spironolactone Tablets (Sun Pharma) - Foreign Substance (2025)

Presence of foreign substance: identified as aluminum.

Class IIModerate

FDAAug 5, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lisdexamfetamine Capsules 60mg (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Class IIModerate

FDAJun 16, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Morphine Sulfate Tablets (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 6, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Decitabine Injection (Sun Pharma) – Microbial Count Issue (2024)

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Class IIModerate

FDAJul 2, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Xelpros (Sun Pharmaceutical) – Failed Particulate Test (2024)

Failed Release Testing: Out of specification for particulate matter test.

FDAApr 22, 2024PA, TX• SUN PHARMACEUTICAL INDUSTRIES INC

Amphotericin B Liposome (Sun Pharmaceutical) – Assay Issue (2024)

Out of specification for assay

Class IIModerate

FDAApr 19, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Febuxostat 40mg (Sun Pharma) – microbial contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAMar 4, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Febuxostat 80mg (Sun Pharma) – microbial contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAMar 4, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Mesalamine Capsules (Sun Pharmaceutical) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAFeb 5, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Kroger Acetaminophen (Sun Pharma) - Packaging Issue (2022)

This recall involves the Kroger brand acetaminophen over-the-counter drug. The red, white and gray label states Kroger, Acetaminophen, Extended-Release Tablets USP, 650mg, Pain Reliever/Fever Reducer, 100 caplets. The bottle has a white continuous thread closure. The UPC number is 041260012877 with the batch codes AC45463, AC38213 or AC30682. The location of the UPC number is under the bar code on the packaging and the batch code is at the bottom of the label on the bottle.

CPSCJun 16, 2022Nationwide• Sun Pharmaceutical Industries Inc., of Princeton, New Jersey