The Recall Desk

Manufacturer

AuroMedics Pharma LLC

36 recalls in our database name AuroMedics Pharma LLC as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
4
Severe
19
Most recent
2022-11-02

Of the 36 recalls from AuroMedics Pharma LLC we have scored against our rubric, 4 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (53%) 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 36

  • HighFDA (Drugs)·D-0020-2023·2022-11-02

    Fondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation

    AuroMedics Pharma LLC is recalling 11,520 units of Fondaparinux Sodium Injection nationwide due to out-of-specification potency. Patients should contact their healthcare provider immediately.

    Product
    FONDAPARINUX SODIUM — FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2023·2022-10-26

    Acyclovir Sodium Injectable Recalled for Particulate Matter

    AuroMedics Pharma is recalling Acyclovir Sodium injection due to dark red, brown, and black particulate matter found in vials. Approximately 89,400 vials were distributed nationwide.

    Product
    ACYCLOVIR SODIUM — ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1551-2022·2022-10-12

    Tranexamic Acid Injection Recalled for Metal Particulate Matter

    AuroMedics Pharma LLC is recalling one lot of Tranexamic Acid Injection due to the presence of metal particles found in a vial. The affected product was distributed nationwide.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0556-2022·2022-02-16

    Polymyxin B for Injection Recalled Due to Particulate Matter Contamination

    AuroMedics Pharma LLC is recalling Polymyxin B for Injection USP (Lot CPB200013) nationwide due to the presence of particulate matter, including hair, found in vials.

    Product
    POLYMYXIN B — POLYMYXIN B (POLYMYXIN B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0853-2020·2020-02-26

    AuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity

    AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection due to elevated levels of Benzaldehyde impurity found in investigative samples.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0852-2020·2020-02-19

    AuroMedics Recalls Amoxicillin and Clavulanate Potassium Tablets Due to Foreign Substance

    AuroMedics Pharma LLC is recalling 30,432 bottles of Amoxicillin and Clavulanate Potassium tablets because a customer complaint identified a nylon cable tie as a foreign substance.

    Product
    AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0789-2020·2020-01-22

    AuroMedics Recalls Moxifloxacin Ophthalmic Solution Due to Discoloration

    AuroMedics Pharma LLC is recalling Moxifloxacin Ophthalmic Solution due to market complaints of discoloration. The affected product is distributed nationwide in the U.S.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2020·2019-12-25

    AuroMedics Recalls Gabapentin Capsules Due to Foreign Tablet Presence

    AuroMedics Pharma LLC is recalling specific lots of Gabapentin Capsules because a Losartan/HCTZ tablet was found in the bottles.

    Product
    Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0637-2020·2019-12-18

    AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error

    AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets that were incorrectly labeled as 7.5 mg. The error affects 500-count bottles distributed nationwide.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0574-2020·2019-12-18

    AuroMedics Recalls Vancomycin Hydrochloride Vials Due to Discoloration

    AuroMedics Pharma LLC is recalling specific lots of Vancomycin Hydrochloride for Injection due to reports of discoloration after reconstitution.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2020·2019-12-18

    AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error

    AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2020·2019-12-11

    AuroMedics Recalls Fluphenazine Decanoate Injection Due to Discoloration

    AuroMedics Pharma LLC is recalling Fluphenazine Decanoate Injection due to discoloration and haziness found in one vial.

    Product
    Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0530-2020·2019-12-04

    Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

    AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0529-2020·2019-12-04

    AuroMedics Recalls Ranitidine Syrup Due to NDMA Contamination

    AuroMedics Pharma LLC is recalling Ranitidine Syrup because N-nitrosodimethylamine (NDMA) has been detected in the product.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0527-2020·2019-12-04

    Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

    AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0528-2020·2019-12-04

    Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

    AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 300 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0526-2020·2019-12-04

    AuroMedics Recalls Ranitidine Tablets Due to NDMA Detection

    AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0573-2020·2019-12-04

    AuroMedics Recalls MARLIDO KIT Vials Due to Foreign Material Presence

    AuroMedics Pharma LLC is recalling MARLIDO KIT vials because foreign material was found inside the vials. The affected product is Lidocaine HCl Injection, USP, 2%.

    Product
    MARLIDO KIT — MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0522-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0521-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0166-2020·2019-11-06

    AuroMedics Recalls Ranitidine Tablets Due to Empty Bottles

    AuroMedics Pharma LLC is recalling one lot of Ranitidine Tablets USP, 150 mg, because some bottles were found to be empty.

    Product
    Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1030-2018·2018-07-18

    AuroMedics Recalls Piperacillin and Tazobactam Injection Vials Due to Particulate Matter

    AuroMedics Pharma LLC is recalling 73,620 vials of Piperacillin and Tazobactam for Injection due to the presence of glass and silicone particulate matter.

    Product
    PIPERACILLIN AND TAZOBACTAM — PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0926-2018·2018-05-23

    AuroMedics Recalls Piperacillin and Tazobactam Injection Due to Glass Particulates

    AuroMedics Pharma LLC is recalling 77,400 vials of Piperacillin and Tazobactam for Injection due to confirmed visible glass particulate matter.

    Product
    PIPERACILLIN AND TAZOBACTAM — PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide