FDA Alert: Recall of Hydrocodone/Acetaminophen 10/500 Tablets

Patient Expert

Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.

The problem with getting too much acetaminophen is that it could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.

The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. For a list of the lot numbers, see Qualitest's press release.

If you have hydrocodone/acetaminophen tablets from the affected lots, contact Qualitest at 1-800-444-4011. If you are unsure if you have the affected lot numbers, you should consult your pharmacy or health care professional.


"Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets" FDA Safety Alert. 12/7/12.