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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

1000

Class I (Serious)

127

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 141–160 of 25000 recalls

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

Azurion R3.0 (Philips) – SSD Spacer Omission (2025)

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

FDAOct 27, 2025Nationwide• Philips North America

Belevini Korushka Smelts (MAMTAKIM) – Botulinum Risk (2025)

Clostridium botulinum (uneviscerated fish)

1...6 789 10...1250

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Class IHigh

FDAOct 27, 2025FL, NJ, NY +2 more• MAMTAKIM, Inc.

Belevini Bichki Smelts (MAMTAKIM) – Botulinum Risk (2025)

Clostridium botulinum (uneviscerated fish)

Class IHigh

FDAOct 27, 2025FL, NJ, NY +2 more• MAMTAKIM, Inc.

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Fresh Herbs (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Sodium Chloride Injection (Otsuka) - Sterility Risk (2025)

Lack of Assurance of Sterility: Potential for flexible container leaks.

Class IIModerate

FDAOct 27, 2025Nationwide• Otsuka ICU Medical LLC

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Coachmen Catalina (Coachmen) – Chassis Frame Tire Puncture (2026)

Forest River, Inc. (Forest River) is recalling certain 2026 Coachmen Catalina travel trailers. The chassis outrigger may contact and puncture the tire.

NHTSAOct 24, 2025Nationwide• COACHMEN

Twin Sisters Peppercorn Cheese (Twin Sisters Creamery) – E. coli Risk (2025)

E. coli

Raw milk Peppercorn cheese is recalled due to E.coli O26:H11

Class IHigh

FDAOct 24, 2025IN, OR, WA• Twin Sisters Creamery, LLC

Twin Sisters Mustard Seed Cheese (Twin Sisters Creamery) – E. coli Contamination (2025)

E. coli

Raw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25.

Class IHigh

FDAOct 24, 2025IN, OR, WA• Twin Sisters Creamery, LLC

Twin Sisters Whatcom Blue Cheese (Twin Sisters Creamery) – E. coli Risk (2025)

E. coli

Raw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.

Class IHigh

FDAOct 24, 2025IN, OR, WA• Twin Sisters Creamery, LLC

Twin Sisters Farmhouse Cheese (Twin Sisters Creamery) – E. coli Contamination (2025)

E. coli

Raw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25.

Class IHigh

FDAOct 24, 2025IN, OR, WA• Twin Sisters Creamery, LLC

Senographe Pristina (GE Medical) – X-Ray Warning Label Missing (2025)

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).

FDAOct 24, 2025Nationwide• GE Medical Systems, LLC

Ram ProMaster (Ram) – Radiator Fan Circuit Issue (2018)

Fire/Burn Risk

Chrysler (FCA US, LLC) is recalling certain 2018-2026 Ram ProMaster vehicles. The electrical circuit for the radiator fan may overheat.

NHTSAOct 23, 2025Nationwide• RAM

Bromocriptine Capsules (Zydus) - Impurity Deviation (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Class IIModerate

FDAOct 23, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Ice Cream Factory Graham Pieces – Foreign Material Risk (2025)

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

Class IIModerate

FDAOct 23, 2025AL, AR, FL +26 more• Ice Cream Factory, LLC

Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc