Safety Alerts & Recalls
What does this mean?
Since Risperidone has serious side effects if overdosed, this recall should be taken seriously. These side effects may include drowsiness, dizziness, nausea, vomiting, anxiety, agitation, restlessness, dreaming more than usual, difficulty falling asleep or staying asleep, fever, muscle stiffness, confusion, fast or irregular pulse, sweating, unusual movements of your face or body that you cannot control, faintness, seizures, and slow movements or shuffling walk.
If you are taking risperidone (Risperdal), look at your prescription to see if it is RISPERIDONE 25 mg tablets manufactured by Dr. Reddy's. The manufacturer is often listed on the prescription label. If you think your tablets are made by Dr. Reddy's, you should return them to your pharmacy immediately to examine and possibly exchange. If you are not sure who has made your tablets, please take your bottle to your pharmacist for them to check as soon as possible.
If you have any other questions about the recall or if you are experiencing side effects, you should contact your physician, pharmacist, or other health care provider.
Recall of Single Lot of Dr. Reddy's Risperidone (plain) 25 mg Tablets
Dr. Reddy's Laboratories Ltd. has recalled a single lot of Risperidone (plain) 25 mg tablets. The lot number involved in the recall is lot number C92847. These recalled tablets may be oversized and contain more drug than appropriate. This could result in patients receiving more than the expected dosage of this drug.
Risperdone is used in the treatment of schizophrenia, bipolar disorder, and the irritability associated with autism. Risperdone is also known by the brand name Risperdal. However, no other lot numbers, strengths, or brands of Risperidone were affected by this recall.
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