East Windsor, NJ, United States
Eugia US LLC recalls
15 recalls recorded since 2018, most recently on 18 May 2026. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)14
Terminated or completed1
Class I (FDA)1
Ongoing Class III Drugs
- Recall started
- 18 May 2026
- Reason
- Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0552-2026
- 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
Ongoing Class II Drugs
- Recall started
- 29 May 2025
- Reason
- Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0472-2025
- 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
Ongoing Class II Drugs
- Recall started
- 21 April 2025
- Reason
- Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0390-2025, D-0389-2025
- 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
- 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
Ongoing Class II Drugs
- Recall started
- 10 April 2025
- Reason
- cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0363-2025
- 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
Ongoing Class II Drugs
- Recall started
- 27 December 2024
- Reason
- Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0186-2025
- 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
Ongoing Class II Drugs
- Recall started
- 18 December 2024
- Reason
- CGMP Deviations
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0185-2025
- 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 Suspe
Ongoing Class II Drugs
- Recall started
- 26 July 2024
- Reason
- Presence of Particulate Matter: Complaint received of a glass particle in the vial.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0624-2024
- 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.
Ongoing Class II Drugs
- Recall started
- 23 May 2024
- Reason
- Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0555-2024
- 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
Ongoing Class III Drugs
- Recall started
- 22 May 2024
- Reason
- Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0556-2024
- 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
Terminated Class II Drugs
- Recall started
- 22 February 2024
- Terminated
- 22 December 2025
- Reason
- Failed Stability Specification: Water determination was found not complying with specification.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0385-2024
- Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470
Ongoing Class II Drugs
- Recall started
- 20 February 2024
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0391-2024, D-0390-2024
- 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
- Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Ongoing Class II Drugs
- Recall started
- 20 February 2024
- Reason
- Failed Dissolution Specifications
- Distribution
- OH, TN, LA, MS
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0366-2024
- Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Ongoing Class I Drugs
- Recall started
- 15 February 2024
- Reason
- Presence of Particulate Matter
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0440-2024
- 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
Ongoing Class II Drugs
- Recall started
- 28 September 2023
- Reason
- Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0041-2024
- Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intra
Ongoing Class II Drugs
- Recall started
- 28 December 2022
- Reason
- Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0095-2023
- Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.