Concentrated Acetaminophen Drop Recall: Possible Dosing Errors

More than 5,600 bottles of concentrated acetaminophen drops for infants have been recalled due to risk of overdose, liver injury or death from dosing errors.

The FDA announced this week that Brookstone Pharmaceuticals LLC issued a concentrated acetaminophen infant drop recall for their 16-ounce bulk containers because they do not contain dosing instructions or a dosage delivery system, which could cause an overdose.

The agency indicated that they are aware of several reports of life-threatening or fatal adverse events in children under three years old due to confusion over dosage.

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Brookstone’s recalled acetaminophen drops are a generic version of Tylenol’s concentrated drops for infants. They contain 80 mg of acetaminophen per every 0.8 ml. However, there are regular strength drops on the market that contain only 160 mg per 5 ml, which the FDA believes may cause dosage confusion.

Brookstone distributed 344 bottles in the United States, and donated 5,301 bottles to charities for international use.

Receiving too much of the medication could increase the risk of acetaminophen liver damage and other injuries. Recent research has shown that acetaminophen is the leading cause of liver failure in the United States, resulting in 56,000 emergency room visits, 26,000 hospitalizations and over 450 deaths annually between 1990 and 2001. Acetaminophen overdoses can also cause kidney damage and blood disorders.

An FDA Advisory Panel was recently convened to review the safety of acetaminophen and the risk of liver injury caused by receiving too much of the medication. The panel recommended that certain limits be placed on the maximum allowed daily dosage for acetaminophen to reduce the risk of injury, and also also recommended a ban on Percocet and Vicodin, as well as other medications that combine acetaminophen with narcotic painkillers.

The FDA has not yet made a decision on their advisory panel recommendations.


  • JeanJuly 29, 2009 at 10:59 pm

    I agree with Jen, adults are dosed by MG and infants are most of the time dosed according to weight. I do have a question though, does anyone know how we could find out if this was a factor in the sudden death of my grandson last year? who could I check with

  • JenJuly 24, 2009 at 7:42 pm

    Perhaps the dosage is right for YOU, Marjorie, however infants and young children require different dosages!

  • MarjorieJuly 17, 2009 at 9:48 pm

    I have fibromyalgia, rheumatoid arthritis, osteo arthritis and have been taking Oxycodone/APAP 7.5/500 for seven years and am checked regularly for liver damage. The test all come back negative. My dosage of acetaminophen per day is 2000 mg or 4 tabs of Oxycodone/APAP 7.50/500 (7.5 of Oxy and 500 of acetaminophen.)..According to what I read this is a safe dosage of a safe drug.

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