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Eugia US LLC

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20232
20248
20256
20261
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FDA Recall Ongoing 2026 recordClass III

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

by Eugia US LLC

Reason
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Published
June 10, 2026
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

by Eugia US LLC

Reason
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Published
June 25, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01

by Eugia US LLC

Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Published
May 7, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

by Eugia US LLC

Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Published
May 7, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01

by Eugia US LLC

Reason
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Published
April 23, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

by Eugia US LLC

Reason
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Published
January 15, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India

by Eugia US LLC

Reason
CGMP Deviations
Published
January 15, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10.

by Eugia US LLC

Reason
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Published
August 7, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Published
June 26, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Published
June 26, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

by Eugia US LLC

Reason
Presence of Particulate Matter
Published
April 17, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Published
March 27, 2024
Distribution
Nationwide

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This page lists recalls that name Eugia US LLC as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.