The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0606-2018·Announced 2018-04-04

Glenmark Recalls Indomethacin Capsules Due to Incorrect Dosage Labeling

Glenmark Pharmaceuticals is recalling Indomethacin Capsules 50 mg because the bottles display incorrect adult dosage instructions.

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 recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding dosage instructions.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Indomethacin Capsules USP, 50 mg, 100-count bottles. The recall was initiated because the product bottles were incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day" instead of the correct dosage of "One capsule 2 or 3 times a day."

The affected product is a prescription-only medication manufactured by Glenmark Pharmaceuticals Ltd. in India for Glenmark Pharmaceuticals Inc., USA. The recall involves 109,080 bottles distributed nationwide in the United States. Specific lot numbers and expiration dates are listed in the recall notice, including lots expiring in July, August, October, and November 2019.

Consumers who have purchased this product should check their bottles for the incorrect dosage instructions. If the label states "One or two capsules 2 or 3 times a day," they should stop using the product and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
INDOMETHACIN (INDOMETHACIN)
Brand
INDOMETHACIN
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Medication
Hazard
Affected units
109,080

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 (15)

  • Lot #: 19172776
  • 19172794
  • Exp 07/19
  • 19173111
  • 19173186
  • 19173188
  • 19173189
  • Exp 08/19
  • 19173852
  • 19173878
  • 19173893
  • Exp 10/19
  • 19174318
  • 19174341
  • Exp 11/19.

UPCs (2)

  • 0368462406014
  • 0368462302019

Distribution

Distributed nationwide across the United States.

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