FDA Drug recall D-1272-2020
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufac…
- FDA Drug
- Class III
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class III recall of Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufac… by Invagen Pharmaceuticals, citing failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1272-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-14 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Identifiers
| ndc | 76282-405-30 |
|---|---|
| ndc | 76282-405-90 |
| ndc | 76282-405-01 |
| ndc | 76282-405-05 |
| ndc | 76282-406-30 |
| ndc | 76282-406-90 |
| ndc | 76282-406-01 |
| ndc | 76282-406-05 |
| code_info | Lot # NB900413, Exp. 12/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1272-2020%22
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