diabetes drug recall
Date of Recall: October 2020

Marksans Pharma Limited Metformin

Marksans is voluntarily expanding an earlier Metformin recall to include more products that may contain NDMA – a probable human carcinogen. The new recall includes 76 batches of Metformin Hydrochloride Extended-Release Tablets USP. The recall includes both 500 mg and 750 mg tablets. Patients taking drugs contaminated with NDMA may be at an increased risk of developing certain types of cancer.  

medication recall
Date of Recall: September 2020

Acella Pharmaceuticals NP Thyroid Tablets

Acella Pharmaceuticals is voluntarily recalling two lots of NP Thyroid 15 and NP Thyroid 120 tablets. The recall stems from tests that showed the tablets contained around 87% of the amount of T4 hormone (levothyroxine) listed on the label. The sub potent drugs could cause serious side effects in patients. 

medication recall
Date of Recall: September 2020

RLC Labs Nature-Throid and WP Thyroid

RLC Labs, Inc. is recalling 483 lots of Nature-Throid and WP Thyroid medications. The medications are used to treat hypothyroidism. According to the FDA, the recalled lots of Nature-Throid and WP Thyroid are sub potent, meaning they do not contain the adequate dose of medication. 

metformin recall
Date of Recall: August 2020

Bayshore Pharmaceuticals Metformin

Bayshore Pharmaceuticals, LLC is voluntarily recalling all Metformin Hydrochloride Extended-Release Tablets USP. They are recalling both 500 mg and 750 mg tablets due to the presence of N-Nitrosodimethylamine (NDMA). NDMA is a probable human carcinogen, meaning it may cause cancer. 

Sundial Herbal Products
Date of Recall: July 2020

Sundial Herbal Products

Sundial Herbal Products is recalling all products distributed between Janary 2014 and present day. The FDA is requesting recall and removal of all products because they are misbranded and misleading. The FDA says that the drugs are not approved for the claims made on the labels, such as curing or treating disease. 

thyroid medication recall
Date of Recall: May 2020

Acella Pharmaceuticals, LLC NP Thyroid

Acella Pharmaceuticals, LLC is recalling certain lots of hypothyroid medication NP Thyroid. The recall follows a test that showed the drug is “superpotent.” Affected lots may contain 115% more liothyronine (T3) than what the label says. Taking superpotent NP Thyroid can cause patients to experience symptoms of overactive thyroid. This is especially dangerous for patients who are pregnant. 

Affected lots include:

NP Thyroid 30 mg

  • Lot M329A19-1, expiration 20-Dec
  • Lot M329H18-1, expiration 20-Jul
  • Lot M329J18-1, expiration 20-Aug
  • Lot M329J18-2, expiration 20-Aug
  • Lot M329J18-3, expiration 20-Aug
  • Lot M329M18-2, expiration 20-Nov

NP Thyroid 60 mg

  • Lot M330J18-2,A expiration 20-Aug
  • Lot M330J18-3, expiration 20-Aug

NP Thyroid 90 mg

  • Lot M331G18-1, expiration 20-Jun
  • Lot M331J18-1, expiration 20-Aug
  • Lot M331J18-2, expiration 20-Aug
  • Lot M331M18-1, expiration 20-Nov
  • Lot M331M18-2, expiration 20-Nov
heartburn medication recall
Date of Recall: April 2020

Amneal Pharmaceuticals, LLC Nizatidine Oral Solution

Amneal Pharmaceuticals, LLC is recalling three lots of Nizatidine Oral Solution. The medication is being recalled to do possible contamination with N-Nitrosodimethylamine (NDMA). NDMA is a probably human carcinogen, meaning it may increase the risk of developing certain cancers. 

The recalled lots include:

  • 06598004A.  Expiration date: 04/2020
  • 06599001A.  Expiration date: 12/2020
  • 06599002A. Expiration date: 12/2020
Belviq recall
Date of Recall: February 2020

Eisai, Co. Belviq

Popular weight loss drug Belviq is being recalled and withdrawn from the market after a study in rats showed an increased risk of cancer while taking the medication. 7.7% of people taking Belviq developed cancer in a study, compared to 7.1% of people taking a placebo. These findings resulted in the FDA requesting recall and withdrawal. 

FDA recall alert, Mirtazapine, medication recall
Date of Recall: December, 2019

Aurobindo Pharma USA, Inc. Mirtazapine

Aurobindo Pharma USA, Inc. is recalling a single lot of Mirtazapine, a popular antidepressant medication. The recall is due to a labeling error that could result in patients taking a higher dose than expected. 

The affected lot is labeled as 7.5 mg, but the pills inside are 15mg. Taking more than recommended can cause adverse side effects. 

drug recall, fda, medication recall
Date of Recall: October, 2019

Takeda Natpara Hypoparathyroid Drug Recall

Takeda Pharmaceutcial Company Limited is recalling all doses of Natpara, a drug used to treat hypoparathyroidism. The recall is due to the potential for rubber particles to enter the drug when puncturing the vial septum.

medication recall, xanax, mylan pharmaceuticals
Date of Recall: October, 2019

Mylan Pharmaceuticals Recalls Batch of Xanax (alprazolam)

Mylan Pharmaceuticals is recalling one batch of Xanax (alprazolam) due to the possibility that the tablets contain a foreign substance. Patients taking the contaminated Xanax could experience infection as a result. 

antacid recalls, medication recalls
Date of Recall: September, 2019

Torrent Pharmaceuticals Limited Expands Losartan Recalls

Torrent Pharmaceuticals Limited is expanding the recall of certain Losartan blood pressure medications. The new recalls include:

Losartan Potassium Tablets USP

  • 13668-409-10 – 50mg, 1000 count, 4DU2E009, expires 12/31/2020
  • 13668-115-90 – 100mg, 90 count, 4DU3E009, expires 12/31/2020
  • 13668-115-10 – 100mg, 1000 count, 4DU3E018, expires 02/28/2021

Losartan Potassium/hydrochlorothiazide tablets USP

  • 13668-116-90 – 50mg/12.5mg, 90 count, BEF7D051, expires 11/30/2020
  • 13668-118-90 – 100mg/25mg, 90 count, 4P04D007, expires 07/31/2020
medication recall, fda recall
Date of Recall: August, 2019

Pfizer, Inc. RELPAX (eletriptan hydrobromide) Tablets

Pfizer is recalling two lots of RELPAX 40mg tablets due to possible contamination with bacteria. According to the U.S. Food and Drug Administration (FDA), the drugs may be contaminated with Burkholderia or Pseudomonas. 

Exposure to these bacterias can cause gastrointestinal distress and possible bacterial dissemination into the bloodstream. 

recall, medication recall
Date of Recall: July, 2019

Bayer Kogenate Mislabeling

Bayer is recalling two lots of Kogenate FS antihemophlic factor 2000 IU vials due to their being mislabeled. Instead of containing the labeled biologic drug, the vials contain Hivi antihemophilic factor PEGylated-aucl 3000 IU. 

medication recall, dry eye
Date of Recall: July, 2019

Altaire Pharmaceuticals, Inc. OTC Natural Tears

Altaire Pharmaceuticals, Inc. is recalling over-the-counter (OTC) “natural tears.” The products, designed to treat dry eye, are being recalled due to possibly being non-sterile. 

The recall includes brand and store brand names, including:

  • Wal-Mart
  • Walgreens
  • CVS
  • OCuSOFT
  • Perrigo
  • Accutome
  • Prestige/Clear Eyes
Date of Recall: March 2019

Alvogen Fentanyl Transdermal System​

Alvogen, Inc. issued a voluntary recall of two lots of Fentanyl Transdermal System 12 mc/h patches due to their being mislabeled. The recalled products were labeled 12 mcg/h, but contained patches that were 50 mcg/h.

Consumers with a recalled product can contact Alvogen Customer Complaints at 566-770-3024.

Date of Recall: Various - November 2018 to March 2019

Losartan Potassium USP

Various recalls have been issued for lots of Losartan Potassium USP tablets found to contain impurities. Ongoing recalls include brand names:
  • Losartan
  • Torrent Pharmaceuticals Limited
  • Macleods
  • Camber Pharmaceuticals, Inc.
  • Legacy Pharmaceutical Packaging, LLC
The common high blood pressure medication has been found to contain impurities including N-Nitrosos M-Methyl 4-amino butyric acid (NMBA), and N-nitrosodiethylamine (NDEA). The impurities are possible human carcinogens.
Date of Recall: March 2019

Mylan Institutional, LLC Levoleucovorin Injection

Mylan Institutional, LLC issued a voluntary recall of two lots of Levoleuocovorin injection 250mg/25ml. The recalled lots were manufactured by Alidac Pharmaceuticals Limited. The recall was issued after the manufacturer discovered particulate matter in the drug, later identified as copper salts. Intravenous administration of copper salts can have severe side effects, and could be life-threatening. Healthcare providers and patients can contact Mylan at 866-551-2706 to find out more, or to report adverse events.
Date of Recall: March 2019

Hospira, Inc. 8.4% Sodium Bicarbonate Injection USP

Hospira, Inc. has voluntarily recalled certain lots of 8.4% Sodium Bicarbonate Injection USP due to particulate matter found in the vials. The particles were identified as glass. Intravenous administration of glass particles can cause serious side effects including clotting or blocking blood vessels, which can cause organ damage.

Date of Recall: March 2019

Apotex Corp. Ethinyl Estradiol Tablets, USP

Apotex Corp. is voluntarily recalling certain lots of Ethinyl Estradiol Tablets due to possibly defective blister packs. The blister packs may be arranged improperly, which could impact dosing. Patients may unknowingly take a placebo instead of the active medication, which could result in unintended pregnancy.

Date of Recall: Various - July 2018 to March 2019

Valsartan and Amlodipine Tablets

Various recalls have been issued for Valsartan and Amlodipine tablets after trace amounts of impurities were detected. The impurity was identified as N-nitrosodiethylamine (NDEA), which is a probable human carcinogen. The ongoing recalls include brand names:

  • Aurobindo
  • Acetris
  • Mylan
  • Teva Pharmaceuticals
  • Torrent Pharmaceuticals Limited
  • Camber Pharmaceuticals, Inc.
  • Actavis
  • Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
  • Major Pharmaceuticals

Valsartan and Amlodipine is used to treat high blood pressure. Patients taking these medications are urged to contact their healthcare providers for more information.

urgent device recall
Date of Recall: February 2019

ICU Medical ChemoLock and ChemoClave Vial Spikes

ICU Medical has voluntarily recalled certain lots of ChemoLock and ChemoClave Vial Spikes after burr particulate was discovered in the vial. The particulate originated from the protective cap that is used during assembly. The burr particulate can enter the bloodstream during intravenous administration, and can result in embolism, organ damage, or stroke.

Date of Recall: February 2019

Dr. Reddy’s Laboratories Ltd.

Dr. Reddy’s Laboratories Ltd. Has recalled a lot of Levetiracetram 0.54% Sodium Chloride Injection single-dose infusion bags. The pre-printed text on the bag was found to be incorrect for the recalled lot. The bags were labeled as 0.75%, but the external foil was labeled as 0.54%.

Incorrect dosage of Sodium Chloride products can result in aggression, respiratory depression, depressed level of consciousness, or coma.

Date of Recall: December 2018

Terrific Care, LLC/Medex Supply Dist., Inc. CoaguChek Test Strips

Terrific Care, LLC/Medex Supply Dist., Inc issued a recall of Roche CoaguChek test strips distributed to U.S. consumers. Patients taking warfarin use the strips to check international normalized ratio (INR) prothrombin levels. The recalled test strips may be defective and may report inaccurate INR levels, which could cause patients to medicate themselves improperly. Over- or under-dosing drugs like warfarin or Coumadin can be dangerous.
Date of Recall: November, 2018

Fresenius Kabi Sodium Chloride Injection, USP, 0.9%

Fresenius Kabi USA recalled 164 lots of Sodium Chloride Injection, USP, 0.9% due to mislabeling. The recalled vials, product inserts, and tray labels all stated that the product did not contain natural rubber latex. The products are being recalled after discovering that the product stoppers did contain rubber latex. Patients who are allergic to latex could suffer an anaphylactic reaction, which can be life-threatening.
Date of Recall: October 2018

Irbesartan Tablets USP 75mg, 150mg, and 300mg

ScieGen Pharmaceuticals, Inc. and Aurobindo Pharma Limited both recalled certain batches of Irbesartan tablets due to impurities found in the drug. The impurity was identified as N-nitrosodimethylamine (NDMA), which is a probable human carcinogen. Both manufacturers issued recalls and urged patients to contact their healthcare providers immediately.

Date of Recall: September 2018

Endo Pharmaceuticals Robaxin 750mg

Endo Pharmaceuticals issued a voluntary recall of two lots of Robaxin (methocarbamol) 750mg tablets. The lots were discovered to have incorrect dosing instructions on the labels. The mislabeled products stated to take “two to four tablets four times daily”, when the label should have stated “two tablets three times daily”. Overdosing on Robaxin can result in seizures, coma, or death.
Date of Recall: September 2018

Pharm D Solutions, LLC Sterile Compounded Drugs

Pharm D Solutions, LLC issued a voluntary recall of all sterile compounded drugs after an FDA inspection indicated pharmacy practices that increase the risk of potential contamination of sterile products. Administering compound drugs that are not sterile can cause serious side effects, and may be life-threatening.

Date of Recall: September 2018

Camber Pharmaceuticals, Inc. Montelukast Tablets

Camber Pharmaceuticals, Inc. has voluntarily recalled a single lot of Montelukast Sodium Tablets 10mg. The recall was issued after a complaint was filed stating that a patient had received a sealed bottle labeled as Montelukast 10mg 30ct tablets, but what was in the bottle was Losartan Potassium 50mg tablets 90ct. Inadvertent use of Losartan can cause renal dysfunction, hypotension, and fatigue. Losartan contains a fetal toxicity warning as well, and therefore should not be used by pregnant women.

Date of Recall: August 2018

Westminster Pharmaceuticals, LLC Levothyroxine and Liothyronine Tablets

Westminster Pharmaceuticals, LLC has voluntarily recalled all lots of Levothyroxine and Liothyronine tablets (15mg, 30mg, 60mg, 90mg, and 120mg) within certain expiration dates. The recall was issued because Westminster found that the products were manufactured using ingredients from Sichuan Friendly Pharmaceutical Co., Ltd. The recalled Levothyroxine and Liothyronine were manufactured prior to the FDA issuing an Import Alert for Sichuan Friendly Pharmaceuticals after finding deficiencies in the Current Good Manufacturing Practices (cGMP). Products failing to meet cGMP could be dangerous.
Date of Recall: July 2018

AuroMedics Pharma LLC Piperacillin and Tazobactam Injection 3.375g Vials

AuroMedics Pharma LLC has voluntarily recalled two lots of Piperacillin and Tazobactam injection vials. The recall comes after vials of the drugs were found to contain particulate matter. One vial was found to contain glass, and the other was found to contain silicone material. The contamination was discovered after complaints had been filed. Administering particulate matter with these drugs could cause local irritation, or blockages or clotting in the blood vessels.
Date of Recall: June 2018

Fagron Sterile Services Neostigmine Methylsulfate

Fagron Sterile Services has recalled two lots of Neostigmine Methylsulfate 5mL syringes. The recalls follows a customer complaint that some syringes were mislabeled. Syringes containing Neostigmine Methylsulfate 1mg/mL, 5mg/5mL were labeled as containing Neostigmine Methylsulfate 1mg/mL, 3mg/3mL. Neostigmine Methylsulfate overdose can cause side effects including nausea and vomiting, bradycardia, tachycardia, bronchospasm, paralysis, or Cholinergic Crisis.

Date of Recall: March 2019
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