AuroMedics Pharma LLC recalls
Every recall we track for AuroMedics Pharma LLC — 36 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them. 10 are rated “stop using now”.
Recalls per year, by danger level
Recalls from AuroMedics Pharma LLC peaked in 2019 (16); 36 since 2017. 28% rated “stop using now”.
All FDA recall records for AuroMedics Pharma LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 0 | 2 |
| 2018 | 4 | 1 | 0 | 6 | 11 |
| 2019 | 5 | 2 | 8 | 1 | 16 |
| 2020 | 0 | 0 | 2 | 1 | 3 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 1 | 2 | 0 | 4 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for AuroMedics Pharma LLC recalls
What to do if you have a recalled AuroMedics Pharma LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All AuroMedics Pharma LLC recalls
23 shown- Lower riskDrug
AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics
AuroMedics recalls Fondaparinux Sodium Injection due to subpotent drug levels. This may not work as intended for blood thinning. Check NDC 55150-232-10 (carton) or 55150-232-00 (syringe) for affected units.
AuroMedicsSep 30, 2022 - Lower riskDrug
AuroMedics Pharma LLC recalls Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma
AuroMedics Pharma recalls Acyclovir Sodium Injection vials due to dark red, brown, and black particulate matter found in the product. This may cause injury if injected.
AuroMedicsSep 26, 2022 - Use cautionDrug
AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by:
AuroMedics Pharma LLC recalls Tranexamic Acid 1000mg/10mL vials due to metal particles found in some batches. This could cause injury during injection. Return or discard affected vials immediately.
AuroMedicsSep 26, 2022 - Stop using nowDrug
AuroMedics Pharma LLC recalls Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only,
AuroMedics Pharma recalls Polymyxin B for Injection due to hair discovered in vials. This sterile prescription drug (NDC 55150-234-10) may contain particulate matter. Affected lots: CPB200013 (exp 9/2022).
AuroMedicsJan 26, 2022 - Lower riskDrug
AuroMedics Pharma LLC recalls Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed
AuroMedics Pharma recalls 100mL IV acetaminophen injection vials with discoloration or failed pH tests. These vials may not be safe for medical use. Check your vials for discoloration or unusual pH levels.
AuroMedicsDec 30, 2020 - UnratedDrug
AuroMedics Pharma LLC recalls Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or
AuroMedics Pharma recalls Glycopyrrolate injection vials with elevated benzaldehyde impurities. This may pose a risk to patients using the medication. Contact the manufacturer for details.
AuroMedicsFeb 7, 2020 - Lower riskDrug
AuroMedics Pharma LLC recalls Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma
AuroMedics Pharma recalls 875mg/125mg amoxicillin-clavulanate tablets due to customer reports of nylon cable ties inside the bottles. This foreign substance may cause choking or injury if swallowed.
AuroMedicsFeb 7, 2020 - Lower riskDrug
AuroMedics Pharma LLC recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed
AuroMedics recalls 0.5% Moxifloxacin eye drops due to discoloration complaints. Affected lots from India with specific expiration dates. Stop using if discoloration occurs.
AuroMedicsDec 2, 2019 - Use cautionDrug
AuroMedics Pharma LLC recalls Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in
AuroMedics Pharma LLC recalls specific lots of Vancomycin Hydrochloride for Injection due to product complaints of discoloration after reconstitution.
AuroMedics PharmaNov 25, 2019 - Lower riskDrug
AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ
AuroMedics Pharma LLC recalls 500-count Mirtazapine 15mg tablets labeled as 7.5mg due to a labeling error. This could lead to incorrect dosing if used without proper medical guidance.
AuroMedicsNov 20, 2019 - Lower riskDrug
AuroMedics Pharma LLC recalls Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
AuroMedics Pharma LLC recalls Gabapentin 100mg capsules (NDC 65682-198-99) due to foreign Losartan/HCTZ tablets found in some bottles. This may cause confusion with other medications.
AuroMedicsNov 19, 2019 - Lower riskDrug
AuroMedics Pharma LLC recalls Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for:
AuroMedics Pharma recalls Fluphenazine Decanoate Injection vials with discoloration or hazy solution. This may affect patients using injectable medication for mental health conditions.
AuroMedicsNov 12, 2019 - Lower riskDrug
AuroMedics Pharma LLC recalls Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per
AuroMedics Pharma recalls 2% Lidocaine HCl injection vials due to foreign material found inside. This product is prescription-only and may pose a risk if used without proper cleaning.
AuroMedicsNov 11, 2019 - Lower riskDrug
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by
AuroMedics Pharma recalls 150mg/3mL Amiodarone injection vials due to visible crystallization. This may cause blockages or reactions. Check NDC 55150-180-03, Lot# CAH180009, exp. Feb 2020.
AuroMedicsNov 11, 2019 - UnratedDrug
AuroMedics Pharma LLC recalls Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo
AuroMedics Pharma LLC recalls Ranitidine Syrup (15 mg/mL) due to detected N-nitrosodimethylamine (NDMA) contamination. This chemical is a potential carcinogen. Consumers with this product should contact the manufacturer for guidance.
AuroMedicsNov 6, 2019 - Lower riskDrug
AuroMedics Pharma LLC recalls Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN
AuroMedics Pharma recalls 150mg Ranitidine tablets due to empty bottles in one lot. Consumers should check NDC 55910-092-79 and lot number NBSB19001DA3 for affected products.
AuroMedicsSep 23, 2019 - Stop using nowDrug
AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for:
AuroMedics Pharma recalls Piperac:illin-Tazobactam injection vials with glass/silicone particles that could cause serious injury. Affected vials have specific NDC and lot numbers.
AuroMedicsJul 2, 2018 - Use cautionDrug
AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx
AuroMedics Pharma recalls single-dose vials of Piperac:illin-Tazobactam injection due to confirmed visible particulate matter (glass) in some units. This may cause serious injury during IV administration. Affected units have specific NDC and lot numbers.
AuroMedicsMay 1, 2018 - Stop using nowDrug
AuroMedics Pharma LLC recalls Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured
AuroMedics Pharma recalls 3g vials of Ampicillin/Sulbactam injections due to reported red rubber particles. Stop using if you have these specific lots.
AuroMedicsMay 1, 2018 - Stop using nowDrug
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous
AuroMedics Pharma recalls specific lots of IV levofloxacin injections due to leaking bags and mold growth between outer packaging and overwrap. Stop using affected products immediately.
AuroMedicsMar 27, 2018 - Stop using nowDrug
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only,
AuroMedics Pharma recalls levofloxacin injection with visible mold particles. Stop using if you have this specific product. Contact for details.
AuroMedicsJan 12, 2018 - Lower riskDrug
AuroMedics Pharma LLC recalls Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil
AuroMedics Pharma recalls Linezolid injection bags with mold particulate matter found in one batch. Stop using affected products immediately to avoid potential health risks.
AuroMedicsDec 20, 2017 - Lower riskDrug
AuroMedics Pharma LLC recalls Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics
AuroMedics recalls Pantoprazole Sodium 40mg injection vials due to glass particles found in one lot. This poses a risk of injury from glass fragments if injected.
AuroMedicsDec 4, 2017
AuroMedics Pharma LLC recall questions
How many recalls has AuroMedics Pharma LLC had?
36 recalls from AuroMedics Pharma LLC are on record with U.S. safety agencies, from 2017–2022.
What is the most recent AuroMedics Pharma LLC recall?
AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics, dated Sep 30, 2022. Every AuroMedics Pharma LLC recall is listed on this page, newest first.
Why are AuroMedics Pharma LLC products recalled?
The most common reasons on record: Crystallization: Presence of visible particulate matter. (3).
What should I do if I have a recalled AuroMedics Pharma LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new AuroMedics Pharma LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.