Drug recall: Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC…

Class III FDA enforcement event 67971. Recall start date: 9 Apr 2014. Status in the FDA record: Terminated. Termination date: 7 Oct 2014.

Reason for recall, in the words of FDA

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Caraco Pharmaceutical Laboratories, Ltd. started this drug recall on 9 Apr 2014. The firm address in the FDA record is in Detroit, MI. FDA put the recall in Class III. FDA event 67971 has 2 product records. The first FDA enforcement report date is 7 May 2014. The record gives the status Terminated, with the termination date 7 Oct 2014.

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

Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI.

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 67971: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1296-2014	Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83	128,363 bottles	Class III	Terminated	7 May 2014
D-1297-2014	Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83	47,813 bottles	Class III	Terminated	7 May 2014

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 III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2014: 313
Share of these events in Class III: 27%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Caraco Pharmaceutical Laboratories, Ltd.
Initiated	Product (first record)	Type	Class	Records
26 Jun 2014	Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 6275	Drug	Class II	2
12 Jun 2014	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distribu	Drug	Class II	1
9 Apr 2014	Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactu	Drug	Class II	1
20 Mar 2014	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 416	Drug	Class II	2
29 Jan 2014	Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 11	Drug	Class II	1
28 Jan 2014	Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc	Drug	Class II	1
5 Nov 2012	traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industrie	Drug	Class II	1
21 Aug 2012	Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per ca	Drug	Class II	1

Caraco Pharmaceutical Laboratories, Ltd.: all 9 events

Official channels

FDA enforcement report D-1296-2014The 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 67971. https://recallregister.com/fda/iii/67971/. 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 67971?: The event has 2 product records. The first record gives this quantity: 128,363 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2014 have the same class?: 27% of the 313 drug events that started in 2014 are in Class III.