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.

26–50 of 59

  • LowFDA (Drugs)·D-1314-2020·2020-06-24

    Aurobindo Pharma Recalls Olanzapine Tablets Due to Impurity Failures

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.

    Product
    Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1231-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1230-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1237-2020·2020-04-22

    Aurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Oxycodone and Acetaminophen tablets because they were manufactured in an area with observed water leakage.

    Product
    OXYCODONE AND ACETAMINOPHEN — OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1229-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1234-2020·2020-04-22

    Aurobindo Recalls Simvastatin Tablets Due to Manufacturing Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Simvastatin 40mg tablets because they were manufactured in an area with observed water leakage.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2020·2019-10-23

    Aurobindo Recalls Amphetamine Mixed Salts Tablets for Out-of-Specification Weight

    Aurobindo Pharma USA Inc. is recalling 11,129 bottles of 20mg Amphetamine Mixed Salts tablets because they failed weight and thickness specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1248-2019·2019-04-17

    Aurobindo Recalls MARBETA L KIT Vials Due to Particulate Matter

    Aurobindo Pharma USA Inc. is recalling 88,600 vials of MARBETA L KIT because one vial was found to contain a hair.

    Product
    MARBETA L KIT — MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1035-2019·2019-03-27

    Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 320 mg because FDA analysis confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1039-2019·2019-03-27

    Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1038-2019·2019-03-27

    Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1037-2019·2019-03-27

    Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1036-2019·2019-03-27

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0361-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA is recalling Amlodipine and Valsartan tablets because FDA testing found NDEA impurity levels above the acceptable daily intake.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0362-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

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

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0367-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling 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-0365-2019·2019-01-23

    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 labs confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) above the interim acceptable daily intake level.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0364-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity NDEA above acceptable daily intake levels.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0370-2019·2019-01-23

    Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Valsartan tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0369-2019·2019-01-23

    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 N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states

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.