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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

125

Past Year

Class I (Serious)

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 41–60 of 125 recalls

Loteprednol Eye Suspension (Sun Pharma) – Potency Issue (2023)

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Class IIILow

FDAJul 5, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Amphotericin B Liposome Injection (Sun Pharmaceutical) – Subpotent Drug (2023)

Subpotent drug

Class IIModerate

FDAMay 30, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Bupropion Hydrochloride Tablets (Sun Pharma) – Failed Dissolution Test (2023)

Failed Dissolution Specifications; during stability testing

Class II

1 234 5...7

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Moderate

FDAMay 9, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Buprenorphine Sublingual Tablets (Sun Pharma) – CGMP Issues (2023)

CGMP Deviations

Class IIModerate

FDAMay 3, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Norepinephrine Bitartrate (Sun Pharmaceutical) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

Class IIILow

FDAMar 29, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Dofetilide 500mcg Capsules (Sun Pharma) – Content Uniformity (2023)

Failed Content Uniformity Specifications

Class IIILow

FDAMar 9, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Diltiazem Hydrochloride Capsules (Sun) - Impurity Failure (2023)

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Class IIModerate

FDAJan 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Oxcarbazepine Tablets 600mg (Sun Pharma) – Foreign Substance (2022)

Presence of foreign substance

Class IIModerate

FDADec 1, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Buprenorphine and Naloxone Sublingual Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Presence of Foreign Substance

Class IIModerate

FDAOct 18, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Pantoprazole Sodium Suspension (Sun Pharmaceutical) – Discoloration (2022)

Discoloration

Class IIModerate

FDAJul 25, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Divalproex Sodium Tablets 500mg (Sun Pharmaceutical) – Dissolution Failure (2022)

Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Class IIModerate

FDAJun 27, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Cypionate Injection (Sun Pharma) – Water Leakage (2022)

cGMP - Water leakage

Class IIModerate

FDAJun 21, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Esomeprazole Magnesium 40mg Capsules (Sun Pharma) – Superpotent Drug (2022)

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Class IIILow

FDAJun 21, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Esomeprazole Magnesium 20mg Capsules (Sun Pharma) – Superpotent Drug (2022)

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Class IIILow

FDAJun 21, 2022Nationwide• 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

Testosterone Cypionate Injection (Sun Pharma) - Sterility Risk (2022)

Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

Class IIModerate

FDAJun 10, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Clonazepam Orally Disintegrating Tablets (Sun Pharma) – Oversized Tablet (2022)

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Cypionate Injection (Sun Pharma) – Machinery Abnormality (2022)

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Cypionate Injection (Sun Pharma) – Manufacturing API Issues (2022)

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Medroxyprogesterone Acetate (Sun Pharma) – Sterility Risk (2022)

Lack of assurance of sterility

Class IIModerate

FDAMay 6, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC