Skip to main content

Is My Product Recalled?

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Scan How It Works Saved Get Alerts

Menu

Search All Recalls Latest Recalls Scan Barcode Get Alerts

Categories

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Resources

How Recalls Work FAQ Recall Classifications Statistics & Trends About

Your Recalls

Loading...

Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

Home
/
Brands
/
Aurobindo Pharma USA Inc.

Aurobindo Pharma USA Inc. Recalls

All product recalls associated with Aurobindo Pharma USA Inc..

Get alerts for this brand

Recall Summary

Total Recalls

58

Past Year

1

Class I (Serious)

2

Most Recent

May 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 21–40 of 58 recalls

Children's Ibuprofen Suspension (Aurobindo) – Missing Dosing Cups (2020)

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

FDAOct 22, 2020NJ• Aurobindo Pharma USA Inc.

Sulfamethoxazole Tablets (Aurobindo) - Metal Wire Contamination (2020)

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

Class IIModerate

FDAAug 10, 2020Nationwide• Aurobindo Pharma USA Inc.

Clozapine Tablets (Aurobindo Pharma) – Tablet Mix-up (2020)

Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Page 2 of 3Next

Moderate

FDAJun 12, 2020Nationwide• Aurobindo Pharma USA Inc.

Olanzapine Tablets (Aurobindo Pharma) – Failed Impurity Test (2020)

Failed Impurities/ Degradation Specifications

FDAMay 26, 2020Nationwide• Aurobindo Pharma USA Inc.

Olanzapine Tablets (Aurobindo) – Impurity Specs (2020)

Failed Impurities/ Degradation Specifications

FDAMay 26, 2020Nationwide• Aurobindo Pharma USA Inc.

Acetaminophen Codeine Tablets (Aurobindo) – Manufacturing Contamination (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Acetaminophen Codeine Tablets (Aurobindo) – Manufacturing Contamination (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Acetaminophen Codeine Tablets (Aurobindo Pharma) – Manufacturing Defect (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Mirtazapine Tablets (Aurobindo) – Manufacturing Contamination (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Levetiracetam Tablets (Aurobindo) – Manufacturing Contamination (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Phentermine Hydrochloride Capsules (Aurobindo) – Manufacturing Contamination (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Gabapentin Capsules (Aurobindo Pharma) – Manufacturing Defect (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Oxycodone Acetaminophen Tablets (Aurobindo) – Manufacturing Contamination (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Simvastatin Tablets (Aurobindo Pharma) – Manufacturing Defect (2020)

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class IIModerate

FDAMar 18, 2020Nationwide• Aurobindo Pharma USA Inc.

Dextroamphetamine Mixed Salts (Aurobindo) – Superpotent Drug (2019)

Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.

Class IIModerate

FDASep 19, 2019Nationwide• Aurobindo Pharma USA Inc.

Simvastatin Tablets (Aurobindo Pharma) - Incorrect Lot Number (2019)

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

FDAJul 29, 2019Nationwide• Aurobindo Pharma USA Inc.

Lidocaine HCl Injection (Aurobindo) – Particulate Contamination (2019)

Presence of Particulate Matter: One vial was found to contain a hair.

FDAMar 28, 2019IN, NM, NC• Aurobindo Pharma USA Inc.

Valsartan/HCTZ Tablets (Aurobindo) – NDEA impurity (2018)

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Hydrochlorothiazide Tablets (Aurobindo) – NDEA Impurity (2018)

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.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Valsartan Tablets (Aurobindo) – NDEA Contamination (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.