Aurobindo Pharma Usa recalls

Aurobindo Pharma Usa appears in 59 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton…
  FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
  Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
• Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810
  FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
  Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
• Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,…
  FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
  Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
• Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton…
  FDA Drug · Class III · 2018-12-12 · Aurobindo Pharma Usa
  Reason: Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
• Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400…
  FDA Drug · Class II · 2017-02-22 · Aurobindo Pharma Usa
  Reason: Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
• Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayt…
  FDA Drug · Class III · 2017-02-15 · Aurobindo Pharma Usa
  Reason: Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
• Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Rout…
  FDA Drug · Class II · 2016-09-21 · Aurobindo Pharma Usa
  Reason: Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
• Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141
  FDA Drug · Class II · 2015-01-14 · Aurobindo Pharma Usa
  Reason: Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
• Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Da…
  FDA Drug · Class III · 2013-06-05 · Aurobindo Pharma Usa
  Reason: Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label