CLASS II Drug recall · Reported 25 Dec 2013 · FDA Enforcement Report

Carisoprodol Tablets, USP 350 mg recalled by West-Ward Pharmaceutical

West-Ward Pharmaceutical is recalling Carisoprodol Tablets, USP 350 mg, distributed nationwide in the US. The recall was initiated on 7 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015

Quantity recalled20,534 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-367-2014
FDA event ID: 67022
Recalling firm: West-Ward Pharmaceutical, Eatontown, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2013
FDA classified: 16 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals

Timeline

7 Nov 2013	Recall initiated by company
16 Dec 2013	Classified by FDA	+39 days
25 Dec 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.

Where it was distributed

Nationwide

Questions about this recall

Is Carisoprodol Tablets, USP 350 mg recalled?

Yes. West-Ward Pharmaceutical recalled Carisoprodol Tablets, USP 350 mg on 7 Nov 2013. The recall is Class II and its status is Terminated. Recall number D-367-2014.

Why was it recalled?

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing

Which lots are affected?

NDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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9 Jul 2014Drug	CLASS II	Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical	West-Ward Pharmaceutical	Potency & Assay	Nationwide

Other Carisoprodol recalls

All 5

Reported	Class	Recall	Company	Reason	Where
19 Mar 2014Drug	CLASS III	Carisoprodol Tablets, USP, 350 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
15 Jan 2014Drug	CLASS II	Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories	Watson Laboratories	Particulate Matter	Nationwide
27 Mar 2013Drug	CLASS III	Carisoprodol Tablets, USP, 350 mg recalled by West-ward Pharmaceutical	West-ward Pharmaceutical	Other	Nationwide
13 Feb 2013Drug	CLASS II	Carisoprodol Tablets, USP, 350 mg recalled by West-ward Pharmaceutical	West-ward Pharmaceutical	Packaging Defects	Nationwide