Amneal Pharmaceuticals, LLC: Drug Recall

Recall Details

Recall Number

D-0402-2025

Classification

Class I

Product Type

Drug

Recalling Firm

Amneal Pharmaceuticals, LLC

Status

Ongoing

Date Initiated

04/17/2025

Location

Bridgewater, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

62 (12x100mL) bags

Reason for Recall

Presence of Particulate Matter

Product Description

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

Distribution Pattern

Nationwide in the US

Other Recalls by Amneal Pharmaceuticals, LLC

• Class II: Risk 08/18/2025
  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
• Class II: Risk 08/18/2025
  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
• Class II: Risk 08/18/2025
  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
• Class II: Risk 08/18/2025
  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
• Class II: Risk 08/18/2025
  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

View all recalls by Amneal Pharmaceuticals, LLC →