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Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. Recalls

All product recalls associated with Lupin Pharmaceuticals 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 2221–2240 of 4747 recalls

Cefdinir Oral Suspension (Lupin) – consistency issue (2019)

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

Class IIModerate

FDAJan 2, 2019Nationwide• Lupin Pharmaceuticals Inc.

Cidofovir Injection (Heritage) – sterility problem (2019)

Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle

Class IIModerate

FDAJan 2, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Cefdinir Oral Suspension (Lupin) – consistency issue (2019)

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

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Class II

Moderate

FDAJan 2, 2019Nationwide• Lupin Pharmaceuticals Inc.

Estradiol Vaginal Inserts (Glenmark) – Defective Applicator (2018)

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Class IIModerate

FDADec 26, 2018Nationwide• Glenmark Pharmaceuticals Inc., USA

Loperamide HCL Tablets (Sun Pharma) – Labeling Mismatch (2018)

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Class IIILow

FDADec 26, 2018OH• Sun Pharmaceutical Industries, Inc.

Ceftriaxone Injection (Lupin) – Rubber Particulate Matter (2018)

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Class IHigh

FDADec 20, 2018Nationwide• Lupin Pharmaceuticals Inc.

Ceftriaxone Injection (Lupin) – Rubber Particulate Matter (2018)

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Class IHigh

FDADec 20, 2018Nationwide• Lupin Pharmaceuticals Inc.

Ceftriaxone Injection (Lupin) – Rubber Particulate Matter (2018)

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Class IHigh

FDADec 20, 2018Nationwide• Lupin Pharmaceuticals Inc.

Temozolomide Capsules (Amerigen) – Failed Dissolution (2018)

Failed Dissolution Specifications

Class IIILow

FDADec 20, 2018Nationwide• Amerigen Pharmaceuticals Inc.

Temozolomide Capsules (Amerigen) – Failed Dissolution (2018)

Failed Dissolution Specifications

Class IIILow

FDADec 20, 2018Nationwide• Amerigen Pharmaceuticals Inc.

Ceftriaxone Injection (Lupin) – Rubber Particulate Matter (2018)

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Class IHigh

FDADec 20, 2018Nationwide• Lupin Pharmaceuticals Inc.

Olmesartan/Hydrochlorothiazide Tablets (Teva) – Failed Dissolution (2018)

Failed dissolution specifications

Class IIModerate

FDADec 19, 2018Nationwide• Teva Pharmaceuticals USA

Toxinout Kit (DrNatura) – product quality issue (2018)

Undeclared Allergen

Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement.

Class IIModerate

FDADec 10, 2018Nationwide• Mylan Pharmaceuticals Inc.

Flora Protect Probiotics (DrNatura) – product issue (2018)

Undeclared Allergen

Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are being recalled due to undeclared soy allergen statement.

Class IIModerate

FDADec 10, 2018Nationwide• Mylan Pharmaceuticals Inc.

Medline Remedy Skin Protectant (US Pharmaceuticals) – microbial contamination (2018)

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Class IIModerate

FDADec 7, 2018Nationwide• US Pharmaceuticals Inc.

Absorica Capsules (Sun Pharmaceutical) – subpotent drug (2018)

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

Class IIILow

FDADec 7, 2018Nationwide• Sun Pharmaceutical Industries, Inc.

Soothe & Cool Skin Protectant (US Pharmaceuticals) – microbial contamination (2018)

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Class IIModerate

FDADec 7, 2018Nationwide• US Pharmaceuticals Inc.

Hydrocortisone Cream (US Pharmaceuticals) – microbial contamination (2018)

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Class IIModerate

FDADec 7, 2018Nationwide• US Pharmaceuticals Inc.

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Aprepitant Capsules (Glenmark) – missing capsule (2018)

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

Class IIILow

FDANov 27, 2018Nationwide• Glenmark Pharmaceuticals Inc., USA