Drug recall: Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only…

Class II FDA enforcement event 38329. Recall start date: 14 Jun 2007. Status in the FDA record: Terminated. Termination date: 28 Aug 2012.

Reason for recall, in the words of FDA

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Apotex Corp. started this drug recall on 14 Jun 2007. The firm address in the FDA record is in Weston, FL. FDA put the recall in Class II. FDA event 38329 has 2 product records. The first FDA enforcement report date is 5 Sep 2012. The record gives the status Terminated, with the termination date 28 Aug 2012.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide.

Recalling firm

Apotex Corp., Weston, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 38329: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1661-2012	Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9	3063	Class II	Terminated	5 Sep 2012
D-1662-2012	Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3	31	Class II	Terminated	5 Sep 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2007: 1
Share of these events in Class II: 100%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 24

Other events of the firm

Other FDA enforcement events of 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

Apotex Corp.: all 24 events

Official channels

FDA enforcement report D-1661-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 38329. https://recallregister.com/fda/ii/38329/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide.
What quantity of product is in FDA event 38329?: The event has 2 product records. The first record gives this quantity: 3063
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2007 have the same class?: 100% of the 1 drug event that started in 2007 are in Class II.