Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0330-2015·Announced 2015-01-14

Aurobindo Pharma Recalls Gabapentin Capsules Due to Empty Capsule Complaints

Aurobindo Pharma USA Inc is recalling 24,816 bottles of Gabapentin 300 mg capsules nationwide because of complaints that the capsules were empty.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 involves a quality control issue (empty capsules) rather than a high-risk pathogen or structural defect, fitting the criteria for moderate severity involving minor labeling or quality errors.

Plain-English summary

Aurobindo Pharma USA Inc is recalling 24,816 bottles of Gabapentin Capsules, USP 300 mg, 100-count bottles. The product is a prescription-only medication manufactured for Northstar Rx LLC and manufactured by Aurobindo Pharma Limited in India. The specific lot affected is GESB14011-A with an expiration date of 12/15.

The recall was initiated due to complaints received regarding empty capsules. The agency has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product: GABAPENTIN (GABAPENTIN)
Brand: GABAPENTIN
Manufacturer: Aurobindo Pharma USA Inc
Category: Drug — Prescription Medication
Hazard: quality-control
empty-capsule
Affected units: 24,816

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 (2)

Lot #: GESB14011-A
Exp 12/15

UPCs (1)

316714662015

Distribution

Distributed nationwide across the United States.

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