US Recalled Medications

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US Recalled Medications

Hundreds of drugs have been recalled in the United States. These voluntary actions by drug companies are a way to protect the public from defective and potentially harmful drugs. Below is a summary of key findings on the latest 30 drug recalls in the United States and changes in medical advice.

List of Recalled Drugs in the United States

  • Drug recalls are voluntary. A company chooses to remove a drug from the market if at any time it finds that the drug is defective.
  • A full list of drugs recalls published by the FDA, along with dates of recalls and reasons for recalls, may be found here. There are a total of 243 entries from 2017 to 2020.
Recalls in 2020
  • Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container were recalled on April 20, 2020. The reason for the recall was out-of-specification results for high molecular weight polymers.
  • Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL were recalled on April 20, 2020. The reason for the recall was presence of particulate matter.
  • Tetracycline HCl Capsules, 250mg and 500mg were recalled on April 16, 2020. The reason for the recall was low out-of-specification dissolution results.
  • Nizatidine Oral Solution 15 mg/mL was recalled on April 15, 2020. The reason for the recall was NDMA (Nitrosodimethylamine) impurity.
  • Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules were recalled on March 26, 2020. The reason for the recall was ampules breaking and shattering.
  • Active Male capsules were recalled on March 16, 2020. The reason for the recall was presence of undeclared tadalafil.
  • Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial was recalled on March 5, 2020. The reason for the recall was potential presence of small particulates.
  • Ranitidine Tablets, USP 150mg were recalls on February 27, 2020. The reason for the recall was NDMA (Nitrosodimethylamine) impurity.
  • Phenytoin Oral Suspension USP, 125 mg/5 mL was recalled on February 21, 2020. The reason for the recall was possible underdosing or overdosing.
  • Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid were recalled on January 31, 2020. The reason for the recall was microbial contamination.
  • Sterile drugs products by AXIA Pharmaceutical were recalled on January 16, 2020. The reason for the recall was lack of assurance of sterility.
  • Lamotrigine Tablets, USP 100mg were recalled on January 10, 2020. The reason for the recall was cross contamination with another drug substance, Enalapril Maleate.
  • Nizatidine Capsules 150mg and 300mg were recalled on January 8, 2020. The reason for the recall was NDMA (Nitrosodimethylamine) impurity.
  • Ranitidine Tablets 150mg and 300mg were recalled on January 7, 2020. The reason for the recall was NDMA (Nitrosodimethylamine) impurity.
Recalls in 2019
  • Mirtazapine Tablets 7.5 mg were recalled on December 31, 2019. The reason for the recall was a label error on declared strength-bottles labeled as Mirtazapine 7.5 mg.
  • Levetiracetam Oral Solution was recalled on December 18, 2019. The reason for the recall was bacillus subtilis. Note that bacillus subtilis is a spore forming, motile, rod-shaped, Gram-positive, facultative aerobe.
  • Ranitidine Tablets 150mg and 300mg were recalled on December 17, 2019. The reason for the recall was NDMA (Nitrosodimethylamine) impurity.
  • Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000 were recalled on December 17, 2019. The reason for the recall was presence of undeclared Tadalafil.
  • Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL were recalled on November 22, 2019. The reason for the recall was potential NDMA (Nitrosodimethylamine) above levels established by the FDA.
  • Ranitidine Oral Solution, USP 150 mg/10 mL was recalled on November 19, 2020. The reason for the recall was potential NDMA (Nitrosodimethylamine) above levels established by the FDA.
  • Ranitidine HCl 150mg and 300mg Capsules were recalled on November 15, 2019. The reason for the recall was potential NDMA (Nitrosodimethylamine) above levels established by the FDA.
  • Male Enhancement Capsules by Silver Bullet were recalled on November 13, 2019. The reason for the recall was an unapproved active ingredient (sildenafil).
  • Ranitidine Liquid Unit Dose Cups were recalled on November 8, 2019. The reason for the recall was NDMA (Nitrosodimethylamine) impurity.
  • Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement was recalled on November 8, 2019. The reason for the recall was the product was found tainted with sildenafil.
  • Ranitidine was recalled on November 6, 2020. The reason for the recall is NDMA (Nitrosodimethylamine) impurity.
  • Sterile injectable products by Viatrexx were recalled on November 5, 2019. The reason for the recall was lack assurance of sterility.
  • LETS GEL KIT Convenience Packs were recalled on November 1, 2019. The reason for the recall was potential microbial contamination in the non-sterile Suturagel.
  • Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP were recalled on October 30, 2019. The reason for the recall was presence of particulate matter.
  • Alprazolam Tablets, USP C-IV 0.5 mg were recalled on October 26, 2019. The reason for the recall was potential presence of foreign substance.
  • Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL was recalled on October 25, 2019. The reason for the recall was NDMA (Nitrosodimethylamine) above levels established by the FDA.

Eight Changes in Medical Advice

  • In July 2019, the FDA revised its advice about eating fish for women who are or might become pregnant, breastfeeding mothers and young children. This is an update on the recommendation from 2017.
  • The update is prompted by the findings that mothers were limiting fish consumption due to concerns of mercury levels. The revised advice does not change the restriction on mercury levels but provides guidelines for the type of fish that is safe for consumption and encourage mothers to consume more of the safe fish. Details of the update may be found here.
  • There are other key changes to the FDA's latest 2015-2020 Dietary Guidelines for Americans.
  • In the guidelines, Americans are recommended to consumer 10% less added sugar--a change from the previous guidelines that only vaguely suggested limiting added sugar intake.
  • With new evidence coming out in recent years, the old "scientific consensus" on sugar has been challenged. It has now directed the world's attention to the previously dismissed theory on how sugar could lead to obesity.
  • Another major change is the recommendation on cholesterol consumption. The guidelines dropped the recommended 300-mg-per-day limit for cholesterol consumption, saying it is no longer "a nutrient of concern."
  • The guidelines also ease the upper limit of sodium consumption, increasing it to 2,300 mg per day. The previous guidelines set the upper limit at 1,500 mg per day for half of the population.
  • Eggs have also seen changes in health advice. In 1968, people were recommended to consume no more than 3 eggs yolks per week.
  • In 2015, the federal guidelines dropped their recommended intake, citing a lack of scientific evidence for a specific limit.
  • Outside of food consumption, one interesting change in medical advice is washing hands. According to a publication on the National Geographic, washing hands was once a controversial piece of advice.
  • After observing deaths in childbirths due to what he believed was the lack of sanitation, a Hungarian Physician Ignaz Semmelweis took his theory on the virtue of hand washing to Vienna Medical Society. His theory was rejected by the medical community because, some historians believe, they were afraid to accept that it would their fault (for not washing their hands) that led to some patients' deaths.
  • He later published articles and a book on the topic and continued to be dismissed by doctors. It was only after his death that the medical community began to recognize the merit of his theory. With the current pandemic, "wash your hands" is a top medical advice although it was once widely rejected by the medical community.
  • Another change in medical advice is the recommended sleeping position for infants. The American Academy of Pediatrics (AAP) revised its recommendation in 1992.
  • The revised recommendation suggests that healthy babies be placed on their backs to sleep. This is to reduce risks of Sudden Infant Death Syndrome (SIDS).
  • Another change to guidelines for babies in the consumption of peanuts, with studies suggesting the risk of allergy can be reduced by as much as 80% with early exposure.
  • The National Institute of Allergy and Infectious Diseases issued new guidelines in 2017 recommending giving peanuts to babies early--in some cases, as early as four months old--to reduce the risk of allergy.
  • In the past, parents were advised to wait until the child is three years old.

Research Strategy

To carry out this research, we pulled information on drug recalls from the FDA's database, where a full list of recalls may be found. We selected the latest 30 recalls to include in the research. As for changes in medical advice, we looked through the FDA's dietary guidelines to select key changes. In addition, we also included a few changes over the years that are covered by the media.
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