Drug recall: Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Ca

FDA enforcement event 69177 · Class III · initiated 18 Apr 2014 · status Terminated · terminated 7 Apr 2017

DrugVoluntary: Firm initiated1 product recordWeston, FL

FDA enforcement event 69177 is a drug recall by Apotex Corp. of Weston, FL, initiated 18 Apr 2014 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 7 Apr 2017. Initiation: voluntary: firm initiated. Apotex Corp. has 24 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Apotex Corp., Weston, FL.

Reason for recall

"Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point."

Distribution

"Nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1609-2014	Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03	5,397 bottles	Class III	Terminated	1 Oct 2014

Context

27%of 2014 drug events are Class III313 events that year

1product record in this eventfirm median: 1

24events on this register for the firm

Other enforcement events for Apotex Corp.

Initiated	Product (first record)	Type	Class	Records
13 Aug 2026	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto,	Drug	Class II	1
8 Apr 2026	Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Ca	Drug	Class II	1
5 Mar 2026	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f	Drug	Class II	1
5 Sep 2025	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufacture	Drug	Class II	2
28 May 2025	Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada	Drug	Class II	3
28 May 2025	Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9	Drug	Class II	1
9 Feb 2024	Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc.	Drug	Class II	1
1 Nov 2023	Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#:	Drug	Class II	4
26 Apr 2023	Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/s	Drug	Class II	1
1 Mar 2023	Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60	Drug	Class II	1

All 24 events for Apotex Corp.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.