CLASS II ONGOING Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report

Montelukast Sodium Tablets, USP, 10 mg recalled

Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 23 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Lot: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025.

Quantity recalleda) 266 Bottles, b) not reported, c) 216 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0518-2023
FDA event ID: 91952
Recalling firm: Preferred Pharmaceuticals, Anaheim, CA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Mar 2023
FDA classified: 6 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Inhalers & Asthma Medication

Timeline

23 Mar 2023	Recall initiated by company
6 Apr 2023	Classified by FDA	+14 days
12 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Product as listed by the FDA

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.

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Is Montelukast Sodium Tablets, USP, 10 mg recalled?

Yes. Preferred Pharmaceuticals recalled Montelukast Sodium Tablets, USP, 10 mg on 23 Mar 2023. The recall is Class II and its status is Ongoing. Recall number D-0518-2023.

Why was it recalled?

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Which lots are affected?

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

Where was it sold?

USA Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Preferred Pharmaceuticals

All 55

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears	Preferred Pharmaceuticals	Sterility	Nationwide
24 Dec 2025Drug	CLASS II	Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled	Preferred Pharmaceuticals	Packaging Defects	CA
7 May 2025Drug	CLASS II	Clindamycin Hydrochloride Capsules, USP, 300mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2024Drug	CLASS II	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled	Preferred Pharmaceuticals	Potency & Assay	CA, NV
29 May 2024Drug	CLASS II	Duloxetine Delayed-Release Cap USP 30mg recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	5 states

Other Montelukast recalls

All 12

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023Drug	CLASS II	Montelukast Sodium Tablets, USP 10 mg recalledMontelukast Sodium	Dr. Reddy's Laboratories	Other	Nationwide
10 May 2023Drug	CLASS II	Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS III	Montelukast Sodium Oral Granules USP, 4 mg recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
5 Apr 2023Drug	CLASS II	Montelukast Sodium Tablets recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium	Accord Healthcare	Manufacturing (CGMP) Deviations	PR