FDA Announces Voluntarily Recall for Batch of Gabapentin 300 MG Capsules

The U.S. Food and Drug Administration (FDA) has reported that Aurobindo Pharma USA is voluntarily recalling Gabapentin 300 mg capsules from lot GESB14011-A in 100-count bottles. The product lot affected was found to include some empty capsules; thus, if taken by a person with seizures, they would not get any active seizure medication. This could result in breakthrough seizures or loss of seizure control, a short-term withdrawal effect, or status epilepticus, a medical emergency. 

People who are currently using Gabapentin 300 mg capsules should check their prescription bottle. If they are taking Gabapentin from this manufacturer and lot number, contact your pharmacist for replacement medication. If a person has noticed a change in seizures or other symptoms, contact the prescribing doctor. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.
• Download form or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
• Read the MedWatch safety alert, which includes a link to the Press Release.