Hydrocodone Bitartrate and Acetaminophen Recall Due to Oversized Pills

A potential risk of oversized pills that may cause a drug overdose has led to the second recall in less than a month for generic hydrocodone bitartrate and acetaminophen tablets. 

Watson Laboratories, Inc. issued a recall for the generic Vicodin on September 20, after it was discovered that two lots of the pills may contain tablets that are thicker than normal and have a darker shade of coloring.

If the pills are too large, it may mean that they have more of the active ingredients, hydrocodone bitartrate and acetaminophen, than they should. This could put consumers at risk of a drug overdose, although there have been no reports of injuries or illnesses associated with the product.

The action comes just 10 days after Qualitest issued a nearly identical recall for hydrocodone bitartrate and acetaminophen tablets due to oversized tablets, impacting one lot of 100 count bottles. It is unclear if there is any connection between the two recalls at this time.

The Watson recall affects Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, 500 count bottles with NDC 00591-0540-05 and lot numbers 519406A and 521759A. Both have expiration dates of April 2014 and were distributed to wholesale distributors and pharmacies nationwide from June 27, 2012 to July 18, 2012.

The affected pills are blue, bisected capsules about 0.6 inches in length with “Watson 540” de-bossed on one side.

Vicodin (hydrocodone and acetaminophen) is a powerful opioid painkiller approved to relieve moderate to severe pain. The brand name version of the drug and generic equivalents that use the same active ingredients are prescribed more than 100 million times a year in the United States.

The hydrocodone component is an opioid painkiller, also known as an opioid pain reliever (OPRs).  It is part of a class of analgesis medications that also includes methadone, oxycodone and morphine. All are powerful controlled substances that can be cause respiratory depression, extreme sedation and death if taken in high quantities.

Acetaminophen is the active pharmaceutical ingredient in Tylenol and a number of other over-the-counter and prescription pain killers. High doses of acetaminophen are known to increase the first of liver problems, including liver failure that may require a transplant.

Overdoses of acetaminophen result in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually, according to data previously provided by the FDA.

Consumers who may have recalled Watson generic Vicodin are being urged to contact their primary health care professional or pharmacy. Pharmacists and wholesalers have been asked by the company to quarantine affected lots and call GENCO Pharmaceutical Services at (800) 950-5479 to receive instructions on returning the recalled pills.