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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 2841–2860 of 4747 recalls

Bupropion Extended Release Tablets (Sun Pharma) – Failed Dissolution (2016)

Failed Dissolution Specifications

Class IIILow

FDAJun 27, 2016Nationwide• Sun Pharmaceutical Industries, Inc.

Alprazolam Extended-release Tablets (Mylan) – Failed Dissolution (2016)

Failed Dissolution Specifications

Class IIModerate

FDAJun 22, 2016Nationwide• Mylan Pharmaceuticals Inc.

Immunity Probiotic Extract (SCD Probiotics) – Misbranded Supplement (2016)

The product is a dietary supplement with drug claims, making the product misbranded.

Class II

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Moderate

FDAJun 17, 2016CA, HI, KS +3 more• Sustainable Community Development LLC dba SCD Probiotics

Methylprednisolone Tablets (Jubilant Cadista) – incorrect expiration date (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.

Class IIILow

FDAJun 13, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Oxacillin Injection (Sagent) – Particulate Matter (2016)

Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.

Class IIModerate

FDAJun 13, 2016Nationwide• Sagent Pharmaceuticals Inc

Seconal Sodium Capsules (Valeant) – missing anaphylaxis warning (2016)

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

Class IIILow

FDAJun 10, 2016Nationwide• Valeant Pharmaceuticals North America LLC

Sunflower Seeds Roasted Salted (Atlantic Spice) – Listeria Risk (2016)

Listeria

Product may be contaminated with Listeria monocytogenes.

Class IHigh

FDAJun 2, 2016AL, CA, CO +27 more• Atlantic Spice Co., Inc.

Tropical Mix (Atlantic Spice) – Potential Listeria (2016)

Listeria

Product was processed on the same equipment as product possibly contaminated with Listeria monocytogenes.

Class IHigh

FDAJun 2, 2016AL, CA, CO +27 more• Atlantic Spice Co., Inc.

Cranberry Health Mix (Atlantic Spice) – Potential Listeria (2016)

Listeria

Product was processed on the same equipment as product possibly contaminated with Listeria monocytogenes.

Class IHigh

FDAJun 2, 2016AL, CA, CO +27 more• Atlantic Spice Co., Inc.

Ceftriaxone Injection (Aidarex) – manufacturing deviation (2016)

CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

Class IIILow

FDAJun 1, 2016GA, IN• Aidarex Pharmaceuticals LLC

Ciprofloxacin Ophthalmic Solution (Aidarex) – impurity detected (2016)

Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

Class IIILow

FDAJun 1, 2016Nationwide• Aidarex Pharmaceuticals LLC

Chlorhexidine Oral Rinse (Aidarex) – impurity detected (2016)

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

Class IIModerate

FDAJun 1, 2016CA, ND, PA +1 more• Aidarex Pharmaceuticals LLC

Irbesartan-Hydrochlorothiazide Tablets (Prinston) – incorrect lot number (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

Class IIILow

FDAMay 30, 2016Nationwide• Prinston Pharmaceutical Inc

Pramipexole Extended Release Tablets (Par) – impurity concern (2016)

Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.

Class IIILow

FDAMay 28, 2016Nationwide• Par Pharmaceutical

Remeven Cream (Stratus) – product crystallization (2016)

Crystallization; Complaints that cream appears to have crystallized

Class IIILow

FDAMay 26, 2016Nationwide• Stratus Pharmaceuticals Inc

Dandruff Care System (Taro Pharmaceuticals) – Subpotent Active Ingredient (2016)

Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.

Class IIILow

FDAMay 26, 2016Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Lodrane D (Valeant) – Mislabeled Carton Packaging (2016)

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

Class IIILow

FDAMay 23, 2016Nationwide• Valeant Pharmaceuticals North America LLC