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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

5

Past Year

4

Class I (Serious)

0

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 1–5 of 5 recalls

Ganirelix Acetate Injection (Lupin) – Impurity Specification (2025)

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Class IIModerate

FDANov 13, 2025FL, MA, MI +1 more• Lupin Pharmaceuticals Inc.

Sertraline Hydrochloride Tablets (Lupin) – defective container (2025)

Defective container - seal not adhering to bottles

Class IIModerate

FDANov 5, 2025Nationwide• Lupin Pharmaceuticals Inc.

Amlodipine Benazepril Capsules (Lupin) – Incorrect Expiration (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

FDAJul 2, 2025Nationwide• Lupin Pharmaceuticals Inc.

Lisinopril/Hydrochlorothiazide Tablets (Lupin) – Product Mix-Up (2025)

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

FDAJun 20, 2025Nationwide• Lupin Pharmaceuticals Inc.

Levothyroxine Tablets 75mcg (Lupin) – impurity specification (2024)

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

FDADec 20, 2024IN, OH• Lupin Pharmaceuticals Inc.