The Recall Desk

Manufacturer

Aurobindo Pharma USA Inc.

59 recalls in our database name Aurobindo Pharma USA Inc. as the manufacturing or recalling firm.

What the numbers show

Total
59
Critical
0
Severe
21
Most recent
2026-08-12

Of the 59 recalls from Aurobindo Pharma USA Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (36%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–59 of 59

  • SevereFDA (Drugs)·D-0366-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0363-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA labs found N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0368-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0289-2019·2018-12-12

    Aurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil tablets because they were found to be pink instead of the expected cream color.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2017·2017-02-22

    Aurobindo Recalls Venlafaxine Hydrochloride Capsules Due to Physical Defects

    Aurobindo Pharma USA Inc is recalling 47,040 bottles of Venlafaxine Hydrochloride extended-release capsules because some contain punctured or clumped capsules.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0470-2017·2017-02-15

    Aurobindo Recalls Discolored Pantoprazole Sodium Injection Vials

    Aurobindo Pharma USA Inc is recalling 29,800 vials of Pantoprazole Sodium for Injection due to discoloration. The affected vials contain powder with a yellowish-brownish appearance.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1499-2016·2016-09-21

    Aurobindo Recalls Pantoprazole Tablets Due to Foreign Tablet Presence

    Aurobindo Pharma USA is recalling specific bottles of Pantoprazole Sodium Delayed-Release Tablets because a foreign tablet was found inside the container.

    Product
    Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-498-2013·2013-06-05

    Aurobindo Recalls Lisinopril Tablets Due to Labeling Error

    Aurobindo Pharma USA Inc is recalling specific lots of Lisinopril 30 mg tablets because the label displays the incorrect strength on the side panel.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Aurobindo Pharma

an Indian pharmaceutical company

Country
India
Founded
1986

Official website

Source: Wikidata (Q4822431), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.