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Class III · Lower riskRecall completed

Gabapentin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # NB900413, Exp. 12/2020
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byInvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788
Brand nameGABAPENTIN
Generic nameGABAPENTIN
Active ingredient(s)GABAPENTIN
Distributed by / forExelan Pharmaceuticals, Inc., Lawrenceville, GA 30046
NDC76282-405-05
Show the full FDA record
Full product labelGabapentin 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 firmInvaGen Pharmaceuticals, Inc.
DistributionNationwide in the U.S.
Quantity2,202 bottles
Recall initiated2020-05-14
Report date2020-05-27
Recall completed2020-08-31
Recall numberD-1272-2020
ClassificationClass III
FDA statusTerminated
Origin on fileHauppauge NY United States

Related

Gabapentin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.