CLASS II Drug recall · Reported 21 Apr 2021 · FDA Enforcement Report

Itraconazole Capsules, 100 mg recalled by Jubilant Cadista

Jubilant Cadista Pharmaceuticals is recalling Itraconazole Capsules, 100 mg, distributed nationwide in the US. The recall was initiated on 1 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021

Quantity recalledLot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 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-0333-2021
FDA event ID: 87667
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2021
FDA classified: 12 Apr 2021
Reported: 21 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

1 Apr 2021	Recall initiated by company
12 Apr 2021	Classified by FDA	+11 days
21 Apr 2021	Published in enforcement report	+9 days

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

Reason for recall

Failed Dissolution Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021

Where was it sold?

Nationwide in the USA

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 26 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 Jubilant Cadista Pharmaceuticals

All 31

Reported	Class	Recall	Company	Reason	Where
11 Jan 2023Drug	CLASS III	Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS III	Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
6 Apr 2022Drug	CLASS I	Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride	Jubilant Cadista Pharmaceuticals	Labeling Errors	5 states

Other Itraconazole recalls

All 4

Reported	Class	Recall	Company	Reason	Where
15 Jun 2016Drug	CLASS II	Itraconazole 0.2%/mupirocin 0.2%/triamcinolone 0.03% Nasal Spray recalled	Well Care Compounding Pharmacy	Sterility	NV
15 Jun 2016Drug	CLASS II	Itraconazole 0.2%/mupirocin 0.2% Nasal Spray recalled	Well Care Compounding Pharmacy	Sterility	NV
22 Jan 2014Drug	CLASS II	Itraconazole, Capsule, 100 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states