FDA Drug recall D-0320-2025
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775,…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775,… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0320-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-13 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.
Reason
CGMP Deviations
Identifiers
| ndc | 68462-126-01 |
|---|---|
| ndc | 68462-126-05 |
| ndc | 68462-127-01 |
| ndc | 68462-127-05 |
| code_info | Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231…Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0320-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.