CLASS III Drug recall · Reported 20 May 2015 · FDA Enforcement Report

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) bottle recalled

Apotex is recalling Olanzapine, Orally Disintegrating Tablets, 10 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 7 Apr 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16

Quantity recalled6,467 bottles/ blister cartons

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-1080-2015
FDA event ID: 71046
Recalling firm: Apotex, Toronto, N/A
Classification: Class III
Status: Terminated
Recall initiated: 7 Apr 2015
FDA classified: 14 May 2015
Reported: 20 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

7 Apr 2015	Recall initiated by company
14 May 2015	Classified by FDA	+37 days
20 May 2015	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

Subpotent drug

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

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent drug

Which lots are affected?

Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16

Where was it sold?

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

Other products in this recall event

2 other products · FDA event 71046

This product is part of a recall event; the main page for the event is Olanzapine, Orally Disintegrating Tablets, 20 mg recalled by Apotex.

Reported	Class	Recall	Company	Reason	Where
20 May 2015	CLASS III	Olanzapine, Orally Disintegrating Tablets, 20 mg recalled by Apotex	Apotex	Potency & Assay	Nationwide
20 May 2015	CLASS III	Olanzapine, Orally Disintegrating Tablets, 5 mg, a) bottle recalled	Apotex	Potency & Assay	Nationwide

More recalls from Apotex

All 75

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled	Apotex	Other	Nationwide
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide

Other Olanzapine recalls

All 16

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS III	Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
25 Dec 2024Drug	CLASS II	Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
9 Mar 2022Drug	CLASS II	Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapine	Macleods Pharma Usa	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide