Drug recall: Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical…

Class III FDA enforcement event 64104. Recall start date: 30 Nov 2012. Status in the FDA record: Terminated. Termination date: 18 Dec 2014.

Reason for recall, in the words of FDA

Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.

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

West-ward Pharmaceutical Corp. started this drug recall on 30 Nov 2012. The firm address in the FDA record is in Eatontown, NJ. FDA put the recall in Class III. FDA event 64104 has 1 product record. The first FDA enforcement report date is 27 Mar 2013. The record gives the status Terminated, with the termination date 18 Dec 2014.

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

Recalling firm

West-ward Pharmaceutical Corp., Eatontown, NJ.

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 64104: product records
Recall number	Product	Quantity	Class	Status	Report date
D-201-2013	Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.	1763 bottles	Class III	Terminated	27 Mar 2013

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 2012: 209
Share of these events in Class III: 28%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 24

Other events of the firm

Other FDA enforcement events of West-ward Pharmaceutical Corp.
Initiated	Product (first record)	Type	Class	Records
13 May 2015	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25	Drug	Class III	1
2 Oct 2014	VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for Versa	Drug	Class II	1
20 May 2014	Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC	Drug	Class II	1
7 Nov 2013	Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mf	Drug	Class II	1
23 Sep 2013	Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured b	Drug	Class II	2
30 Jul 2013	Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles	Drug	Class II	1
30 Jul 2013	Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bot	Drug	Class II	1
4 Jun 2013	VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorpora	Drug	Class II	1
16 May 2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle	Drug	Class II	2
13 May 2013	Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Scien	Drug	Class III	1

West-ward Pharmaceutical Corp.: all 24 events

Official channels

FDA enforcement report D-201-2013The 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 64104. https://recallregister.com/fda/iii/64104/. 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 64104?: The FDA record gives this quantity: 1763 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2012 have the same class?: 28% of the 209 drug events that started in 2012 are in Class III.