The Recall Desk
ModerateFDA (Drugs)·D-0400-2023·Announced 2023-03-08

Accord Healthcare Recalls Montelukast Sodium Tablets Due to Manufacturing Deviations

Accord Healthcare recalls approximately 665,469 bottles of Montelukast Sodium 10 mg tablets due to manufacturing process deviations discovered during FDA inspection.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is manufacturing process deviations identified during inspection, which is precautionary in nature rather than a directly identified safety threat.

Plain-English summary

Accord Healthcare, Inc. is recalling approximately 665,469 bottles of Montelukast Sodium Tablets, USP, 10 mg, distributed in the United States (including Puerto Rico) and Canada. The recall affects multiple package sizes: 30-count, 90-count, and 1,000-count bottles.

The recall was initiated following an FDA inspection that identified deviations from current good manufacturing practice (CGMP) standards. CGMP deviations can affect the consistency and quality of the product. No illnesses or injuries related to this product have been reported.

Patients currently taking Montelukast Sodium should consult their healthcare provider before discontinuing the medication. Consumers are advised to return recalled bottles to their pharmacy or contact Accord Healthcare, Inc. for instructions on obtaining replacement product.

The recalled product

Product
MONTELUKAST SODIUM (MONTELUKAST SODIUM)
Brand
MONTELUKAST SODIUM
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
665,469

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 (20)

  • Batches: a) R2000831
  • Exp. Date 11/30/2023
  • R2000832
  • R2200661
  • Exp. Date 5/31/2025
  • b)R2000836
  • R2000837
  • R2000838
  • R2000840
  • R2000842
  • R2000835
  • R2000841
  • R2000833
  • R2100310
  • R2100311
  • R2100314
  • R2100312
  • R2100313
  • R2100315
  • R2100316

UPCs (4)

  • 0316729119108
  • 316729119108
  • 316729119153
  • 316729119177

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. 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 67 products in this recall →

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