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.

1–25 of 59

  • ModerateFDA (Drugs)·D-0733-2026·2026-08-12

    Dicyclomine Hydrochloride Capsules Recalled for Empty Capsules

    Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.

    Product
    DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0471-2025·2025-06-25

    Amazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration

    Aurobindo Pharma USA Inc is recalling Amazon Basic Care Acetaminophen 325 mg tablets due to confirmed consumer complaints of brown surface discoloration on tablets, a cGMP deviation.

    Product
    AMAZON BASIC CARE ACETAMINOPHEN — AMAZON BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0079-2025·2024-12-11

    Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit

    Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.

    Product
    Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 658
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0077-2025·2024-12-11

    FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity

    Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.

    Product
    Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2025·2024-12-11

    Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity

    Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.

    Product
    Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0641-2024·2024-08-28

    Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels

    Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.

    Product
    ACETAMINOPHEN ASPIRIN AND CAFFEINE — ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0492-2024·2024-05-15

    Clorazepate Dipotassium Tablets Recalled for Tablet Discoloration Defects Nationwide

    Aurobindo Pharma USA Inc. is recalling 6909 bottles of Clorazepate Dipotassium 7.5 mg tablets due to visible discoloration with yellow and dotted spots. No illnesses or injuries have been reported.

    Product
    CLORAZEPATE DIPOTASSIUM — CLORAZEPATE DIPOTASSIUM (CLORAZEPATE DIPOTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0491-2024·2024-05-15

    Clorazepate Dipotassium Tablets Recalled Due to Cosmetic Discoloration

    Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets 3.75 mg due to yellow dots and discoloration on some tablets distributed nationwide.

    Product
    CLORAZEPATE DIPOTASSIUM — CLORAZEPATE DIPOTASSIUM (CLORAZEPATE DIPOTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1171-2023·2023-09-27

    Rasagiline Tablets Recalled Due to Failed Dissolution Specifications

    Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.

    Product
    Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1087-2023·2023-08-30

    Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1088-2023·2023-08-30

    Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 400 mg tablets due to manufacturing quality deviations. The affected batch was released prior to approval.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0765-2023·2023-05-31

    Pain Reliever Caplets Recalled Due to Out-of-Specification Impurity

    Aurobindo Pharma is recalling 87,360 bottles of Pain Reliever Acetaminophen caplets (500 mg) distributed nationwide through Walgreens due to failed impurity specifications discovered through customer complaints about discoloration.

    Product
    PAIN RELIEVER — PAIN RELIEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0021-2023·2022-11-02

    Quinapril and Hydrochlorothiazide Tablets Recalled Due to Manufacturing Impurity

    Aurobindo Pharma USA Inc. is recalling Quinapril/Hydrochlorothiazide Tablets 20mg/12.5mg due to N-nitroso-quinapril impurity above acceptable limits from manufacturing deviations. Affected lots QE2021005-A and QE2021010-A were distributed nationwide.

    Product
    QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE (QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0766-2022·2022-04-20

    Cyanocobalamin Injection Recalled for Subpotent Drug - Out of Specification Assay

    Aurobindo Pharma USA Inc. is recalling 433,809 vials of Cyanocobalamin injection nationwide because assay testing showed the drug is subpotent, containing less than the specified 1,000 mcg/mL of active ingredient. Affected lots with specific expiration dates from September 2022 to April 2023 are identified for recall.

    Product
    CYANOCOBALAMIN — CYANOCOBALAMIN (CYANOCOBALAMIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0560-2022·2022-02-23

    Moxifloxacin Ophthalmic Solution Recall for Failed Impurities Specifications

    Aurobindo Pharma USA Inc. is recalling Moxifloxacin Ophthalmic Solution 0.5% due to failed impurities and degradation specifications. The recall affects 115,776 bottles distributed nationwide.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2022·2022-02-02

    Pioglitazone Tablets Recalled for Superpotent and Failed Specifications

    Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.

    Product
    PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0263-2022·2021-12-01

    Carvedilol Tablets Recalled for Failed Impurities and Degradation Specifications

    Aurobindo Pharma USA Inc. is recalling Carvedilol 6.25 mg tablets nationwide due to failed impurities and degradation specifications. Affected containers bear Batch QG0619030-A with expiration date 11/2022.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0812-2021·2021-09-29

    Metoprolol Tartrate Tablets Recalled for Metal Wire Contamination

    Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate 100 mg tablets due to the presence of metal wire found in at least one tablet. The FDA classified this as a Class II recall affecting 2,820 bottles distributed nationwide.

    Product
    METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0719-2021·2021-08-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination

    Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1535-2020·2020-09-02

    Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire

    Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1370-2020·2020-07-01

    Aurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence

    Aurobindo Pharma USA is recalling 1,440 bottles of Clozapine 100mg tablets because a consumer reported finding 50mg tablets in the 100mg bottles.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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

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.