The Recall Desk
HighFDA (Drugs)·D-0518-2023·Announced 2023-04-12

Montelukast Sodium Tablets Recalled for Manufacturing Deviations

Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg due to current Good Manufacturing Practice deviations discovered during an FDA inspection. The product was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for manufacturing deviations with no reported illnesses or injuries. FDA Class II recalls without hospitalization reports and with theoretical hazards score at a maximum of 3 per the severity rubric.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Montelukast Sodium Tablets, USP, 10 mg in three packaging sizes: 30-count bottles (NDC 68788-9438-3), 60-count bottles (NDC 68788-9438-6), and 90-count bottles (NDC 68788-9438-9). The product is manufactured by Accord Healthcare, Inc. in Durham, North Carolina.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations discovered during an FDA inspection of the manufacturing facility.

The affected product was distributed nationwide. Specific lot numbers and expiration dates include: 30-count bottles (Lot F3021D, Exp 12/31/2023; Lot L0722T, Exp 5/31/2025); 60-count bottles (Lot F1021I, Exp 12/31/2023); and 90-count bottles (Lot H1721R, Exp 12/31/2023; Lot L0722E, Exp 5/31/2025).

The recalled product

Product
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Prescription
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 (8)

  • a) Lot: F3021D
  • Exp 12/31/2023
  • Lot: L0722T
  • Exp 5/31/2025
  • b) Lot: F1021I
  • c) Lot:H1721R
  • Lot: L0722E
  • Exp 5/31/2025.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, 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 17 products in this recall →

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