The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0821-2021·Announced 2021-09-29

Glenmark Naproxen Sodium Tablets recalled for CGMP deviations

Glenmark Pharmaceuticals is recalling 9,552 bottles of Naproxen Sodium Tablets USP 275 mg nationwide due to CGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility.

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: This is an FDA Class II recall for CGMP deviations. The source text does not report any illnesses, injuries, or adverse events; the hazard is compliance-related manufacturing practice, not product harm. Per the rubric, Class II recalls without reported illness or injury are rated 2 (Moderate).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 275 mg (100 tablets per bottle, NDC 68462-178-01) due to CGMP deviations. The recall affects 9,552 bottles distributed nationwide.

The affected lots are: 29190087 (Exp. 10/31/2021), 29190088 (Exp. 10/31/2021), 29190089 (Exp. 10/31/2021), 29200077 (Exp. 11/30/2022), and 29200078 (Exp. 11/30/2022). The product is manufactured by Glenmark Pharmaceuticals Inc., USA at 4147 Goldmine Road, Monroe, NC 28110.

The recall is voluntary and was initiated by the firm on August 27, 2021, following FDA notification of CGMP deviations at the manufacturing facility. This is a Class II recall. Patients taking this medication should consult their healthcare provider or pharmacist about whether to continue use or obtain replacement product from an alternative source.

The recalled product

Product
NAPROXEN SODIUM (NAPROXEN SODIUM)
Brand
NAPROXEN SODIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription NSAID
Hazard
Affected units
9,552

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 (6)

  • Lots: 29190087 Exp. 10/31/2021
  • 29190088 Exp. 10/31/2021
  • 29190089 Exp. 10/31/2021
  • 29200077 Exp. 11/30/2022
  • 29200078 Exo
  • 11/30/2022

UPCs (5)

  • 0368462189016
  • 0368462178010
  • 0368462179017
  • 0368462188019
  • 0368462190012

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Glenmark Pharmaceuticals 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 8 products in this recall →

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