Safety Alerts & Recalls

What does this mean?

The recalled lots of Phenobarbital Tablets, 32.4mg, from Qualitest Pharmaceuticals were distributed between September 21, 2010 and December 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Patients who have received prescriptions for Phenobarbital Tablets, 32.4mg between September 2010 and February 2011 may be affected by the recall.

If you take Phenobarbital Tablets, 32.4mg, please check your medicine to see if it was made by Qualitest. The manufacturer's name is often listed on the prescription label. If your Phenobarbital Tablets, 32.4mg are made by Qualitest, they should be small, white, round, scored tablets, with (5012) and (V) imprinted on one side, and plain on the reverse side.

If you think your tablets are made by Qualitest and possibly involved in the recall, or if you think your tablets look different than what you normally receive, take your prescription to your pharmacist to examine. Consumers with questions may also contact Qualitest at 1-800-444-4011 for more information.

If you take Phenobarbital and have medical concerns, please follow up with your doctor.

Healthcare professionals and patients re encouraged to report adverse events or side effects related to the use of this medicine to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Qualitest Recalls Phenobarbital Tablets Because of Incorrect Package Labeling

Qualitest Pharmaceuticals has issued a voluntary nationwide recall of Phenobarbital Tablets, USP 32.4mg, NDC 0603-5166-32, lot numbers T150G10B, T120J10E and T023M10A. These lots of Phenobarbital Tablets, 32.4mg are being recalled because an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled as Phenobarbital Tablets USP, 32.4mg, NDC 0603-5166-32, 1000 count.

As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression (slowed breathing), depression of the central nervous system (drowsiness, slower heart rate, loss of motor skills, unclear speech, unclear thinking and unclear vision), coma, and death, especially in opioid naive patients and patients on other medicines that cause depression of the central nervous system. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.

Phenobarbital is used to prevent seizures. It is made by many different manufacturers and comes in several strengths. This recall alert only applies to the select lots of the Phenobarbital Tablets, USP 32.4mg, NDC 0603-5166-32, 1000 count from Qualitest. No other Phenobarbital products are involved in this recall.

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Source: FDA
Publication Date: 2011-02-07
Last Updated: 2011-02-07

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