The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-329-2013·Announced 2013-05-22

Glenmark Recalls Gabapentin Tablets Due to Chemical Contamination and Off-Odor

Glenmark Generics Inc. is recalling Gabapentin tablets due to complaints of a moldy, musty, or fishy odor. The FDA classifies this as a Class III recall.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classifies this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Glenmark Generics Inc., USA is recalling Gabapentin tablets, a prescription medication, due to chemical contamination. The recall is prompted by complaints regarding an off-odor described as moldy, musty, or fishy in nature.

The affected products are Gabapentin tablets in 600 mg and 800 mg strengths, packaged in 500-count bottles. The specific NDC codes are 68462-126-05 and 68462-127-05. The recall covers specific lots with expiration dates ranging from October 2014 to November 2014. The products were distributed nationwide.

The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
GABAPENTIN (GABAPENTIN)
Brand
GABAPENTIN
Manufacturer
Glenmark Generics Inc., USA
Category
Drug — Prescription Medication
Hazard

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 (14)

  • a) 600mg: Lot# 02123419
  • Exp 10/14 Lot# 02123424
  • Exp 10/14 Lot# 02123430
  • Exp 10/14 Lot# 02123492
  • Exp 10/14 Lot# 02123523
  • Exp 10/14 Lot# 02123527
  • Exp 10/14 Lot# 02123532
  • Exp 10/14 Lot# 02123542
  • Exp 10/14 Lot# 02123546
  • Exp 10/14 Lot# 02123551
  • Exp 10/14 Lot# 02123555
  • Exp 10/14 Lot# 02123560
  • Exp 11/14 Lot# 02123566
  • Exp 11/14 Lot# 02123569

UPCs (2)

  • 0368462127018
  • 0368462126011

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Glenmark Generics Inc., USA 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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