Drug recall: Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay…

Class I FDA enforcement event 84645. Recall start date: 20 Dec 2019. Status in the FDA record: Terminated. Termination date: 23 Feb 2024.

Reason for recall, in the words of FDA

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Taro Pharmaceuticals U.S.A., Inc. started this drug recall on 20 Dec 2019. The firm address in the FDA record is in Hawthorne, NY. FDA put the recall in Class I. FDA event 84645 has 1 product record. The first FDA enforcement report date is 19 Feb 2020. The record gives the status Terminated, with the termination date 23 Feb 2024.

FDA enforcement report The 1 product record

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 in the U.S. and Puerto Rico.

Recalling firm

Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY.

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

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

Products

1 product record in the event.

FDA event 84645: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0833-2020	Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.		Class I	Terminated	19 Feb 2020

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 I: The highest of the three FDA recall classes.

The event in context

Drug events that started in 2019: 362
Share of these events in Class I: 10%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 21

Other events of the firm

Other FDA enforcement events of Taro Pharmaceuticals U.S.A., Inc.
Initiated	Product (first record)	Type	Class	Records
7 Aug 2024	Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, O	Drug	Class III	1
25 Feb 2022	Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceutica	Drug	Class III	1
15 Dec 2021	Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay,	Drug	Class I	1
8 Jan 2021	Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2	Drug	Class II	1
17 Nov 2020	CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharma	Drug	Class II	10
20 Jul 2020	Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For E	Drug	Class III	1
7 Feb 2020	Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Lt	Drug	Class I	1
27 Sep 2019	Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., B	Drug	Class II	5
19 Oct 2018	Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 F	Drug	Class II	3
21 Dec 2017	Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israe	Drug	Class III	1

Taro Pharmaceuticals U.S.A., Inc.: all 21 events

Official channels

FDA enforcement report D-0833-2020The 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 84645. https://recallregister.com/fda/i/84645/. 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 in the U.S. and Puerto Rico.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?: 10% of the 362 drug events that started in 2019 are in Class I.
How many FDA recalls does Taro Pharmaceuticals U.S.A., Inc. have?: Taro Pharmaceuticals U.S.A., Inc. is the recalling firm in 21 enforcement events on this register. This event is 1 of them.