CLASS II Drug recall · Reported 14 Jan 2015 · FDA Enforcement Report
Gabapentin Capsules, USP, 100 mg recalled by Actavis Elizabeth
Actavis Elizabeth is recalling Gabapentin Capsules, USP, 100 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
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-0338-2015
- FDA event ID
- 70001
- Recalling firm
- Actavis Elizabeth, Elizabeth, NJ
- Brand
- Gabapentin
- Manufacturer
- Actavis Pharma, Inc.
- 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, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, 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.
Where it was distributed
Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016
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 70001This product is part of a recall event; the main page for the event is Gabapentin Capsules, USP, 300 mg recalled by Actavis Elizabeth.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Gabapentin Capsules, USP, 300 mg recalled by Actavis ElizabethGaba 300-ezs | Actavis Elizabeth | Other | PR | |
| CLASS II | Gabapentin Capsules, USP, 400 mg recalled by Actavis ElizabethGabapentin | Actavis Elizabeth | Other | PR |
More recalls from Actavis Elizabeth
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth | Actavis Elizabeth | Other | NJ |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
Other Gabapentin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg , blister pack recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Gabapentin Capsules, USP 300 mg recalledGabapentin | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |