Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is GABAPENTIN recalled?

The FDA has recorded 10 recalls of GABAPENTIN (2023–2025) , recalled under brand like GABAPENTIN. 7 still ongoing.

0
Class I (most serious)
6
Class II
4
Class III
7
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of GABAPENTIN ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing f 2
Cross Contamination 2
Defective container; blister packaging inadequately sealed. 2
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabape 1
CGMP Deviations 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmac Class II ongoing
The Harvard Drug Group LLC 2025-10-10 lots: Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-03-13 lots: 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
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJO Class II ongoing
The Harvard Drug Group LLC 2025-06-19 lots: Lot# M05205, Exp Date 10/2026
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Phar Class II ongoing
The Harvard Drug Group LLC 2025-10-10 lots: Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICAL Class II ongoing
The Harvard Drug Group LLC 2025-06-19 lots: Lot# M05205A and M05205B, Exp Date 10/2026.
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, Class II Terminated
Granules Pharmaceuticals Inc. 2024-07-31 lots: Lot 1380040A, Exp. date July 31, 2025
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC Class III ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-03-04 lots: Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND Class III ongoing
SUN PHARMACEUTICAL INDUSTRIES INC 2025-03-04 lots: Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge Class III Terminated
Sciegen Pharmaceuticals Inc 2023-02-17 lots: Lot # G177092, Exp. 11/24
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu Class III Terminated
The Harvard Drug Group 2023-04-24 lots: Lot: T04468, Exp 10/2024

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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