The Recall Desk
ModerateFDA (Drugs)·D-0337-2015·Announced 2015-01-14

Actavis Recalls GABA 300-EZS Gabapentin Capsules Due to Physical Defects

Actavis Elizabeth LLC is recalling GABA 300-EZS (Gabapentin) capsules distributed in Puerto Rico due to reports of 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, but the source text describes physical defects (clumping, breaking, packaging issues) without reporting any illnesses or injuries, aligning with the 'Moderate' severity criteria for low-risk contamination or minor defects.

Plain-English summary

Actavis Elizabeth LLC is recalling 24,240 bottles of GABA 300-EZS (Gabapentin) Capsules, USP, 300 mg. The affected product is a prescription medication distributed in Puerto Rico. The recall involves specific lots: G01960A1 (Exp 09/2015) and G01967A1 (Exp 10/2015).

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

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
GABA 300-EZS (GABAPENTIN)
Brand
GABA 300-EZS
Manufacturer
Actavis Elizabeth LLC
Category
Drug — Prescription Medication
Hazard
Affected units
24,240

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: G01960A1
  • Exp 09/2015
  • G01967A1
  • Exp 10/2015

UPCs (1)

  • 0731477272217

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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