Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Gabapentin Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
What was recalled
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 76282-405-05
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1272-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Gabapentin recalls
See all
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Gabapentin Tablets 600mg
Reason CGMP Deviations
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