CLASS II Drug recall · Reported 14 Jan 2015 · FDA Enforcement Report

Gabapentin Capsules, USP, 300 mg recalled by Actavis Elizabeth

Actavis Elizabeth is recalling Gabapentin Capsules, USP, 300 mg, distributed in Puerto Rico. The recall was initiated on 15 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015

NDC59088-725

UPC0731477272217

Quantity recalled24,240 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0337-2015
FDA event ID: 70001
Recalling firm: Actavis Elizabeth, Elizabeth, NJ
Brand: Gaba 300-ezs
Manufacturer: PureTek Corporation
Classification: Class II
Status: Terminated
Recall initiated: 15 Dec 2014
FDA classified: 8 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Pain Medication

Timeline

15 Dec 2014	Recall initiated by company
8 Jan 2015	Classified by FDA	+24 days
14 Jan 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Product as listed by the FDA

Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11

Where it was distributed

Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015

Where was it sold?

Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 70001

Reported	Class	Recall	Company	Reason	Where
14 Jan 2015	CLASS II	Gabapentin Capsules, USP, 400 mg recalled by Actavis ElizabethGabapentin	Actavis Elizabeth	Other	PR
14 Jan 2015	CLASS II	Gabapentin Capsules, USP, 100 mg recalled by Actavis ElizabethGabapentin	Actavis Elizabeth	Other	PR

More recalls from Actavis Elizabeth

All 14

Reported	Class	Recall	Company	Reason	Where
30 Nov 2016Drug	CLASS III	NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth	Actavis Elizabeth	Other	NJ
13 Apr 2016Drug	CLASS II	Dextroamphetamine Saccharate, Amphetamine Aspartate recalled	Actavis Elizabeth	Potency & Assay	Nationwide
13 Apr 2016Drug	CLASS II	Dextroamphetamine Saccharate, Amphetamine Aspartate recalled	Actavis Elizabeth	Potency & Assay	Nationwide
13 Apr 2016Drug	CLASS II	Dextroamphetamine Saccharate, Amphetamine Aspartate recalled	Actavis Elizabeth	Potency & Assay	Nationwide
13 Apr 2016Drug	CLASS II	Dextroamphetamine Saccharate, Amphetamine Aspartate recalled	Actavis Elizabeth	Potency & Assay	Nationwide

Other Gabapentin recalls

All 22

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide
9 Jul 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin	The Harvard Drug Group	Packaging Defects	Nationwide
9 Jul 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg , blister pack recalled	The Harvard Drug Group	Packaging Defects	Nationwide
16 Apr 2025Drug	CLASS III	Gabapentin Capsules, USP 300 mg recalledGabapentin	SUN Pharmaceutical Industries	Packaging Defects	Nationwide