The Recall Desk
ModerateFDA (Drugs)·D-0338-2015·Announced 2015-01-14

Actavis Recalls Gabapentin Capsules Due to Physical Defects

Actavis Elizabeth LLC is recalling 29,622 bottles of Gabapentin capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes physical defects (clumping, breaking, packaging issues) without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.

Plain-English summary

Actavis Elizabeth LLC is recalling 29,622 bottles of Gabapentin Capsules, USP, 100 mg. The affected products are prescription-only capsules manufactured by Actavis Pharma Manufacturing Pvt. Ltd. in India and distributed by Actavis Elizabeth LLC in Elizabeth, New Jersey. The recall covers two specific lot numbers: G01966A1 (expiration 10/2015) and G02004A1 (expiration 03/2016), available in 100-capsule and 500-capsule bottles.

The recall was initiated after Actavis received complaints regarding physical defects in the product. These defects include clumping and breaking of the capsules, bottles with popped-out round bottoms, and creased labels. The issues were identified from one distribution center.

The affected products were distributed in Puerto Rico. Consumers and healthcare providers should stop using the recalled Gabapentin capsules and contact their healthcare provider or pharmacist for a replacement or further instructions.

The recalled product

Product
GABAPENTIN (GABAPENTIN)
Brand
GABAPENTIN
Manufacturer
Actavis Elizabeth LLC
Category
Drug — Prescription Medication
Hazard
Affected units
29,622

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #s: a) G01966A1
  • Exp 10/2015
  • b) G02004A1
  • Exp 03/2016

UPCs (2)

  • 0345963555113
  • 0345963556110

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Actavis Elizabeth LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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