CLASS II Drug recall · Reported 13 Feb 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 Dec 2012 and the FDA has classified it as Class II.
Check your package
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-150-2013
- FDA event ID
- 64103
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2012
- FDA classified
- 5 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 7 Dec 2012 | Recall initiated by company | |
| 5 Feb 2013 | Classified by FDA | +60 days |
| 13 Feb 2013 | Published in enforcement report | +8 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: Uncharacteristic blacks spots on tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Which lots are affected?
Lot #: 69364A, 69365A, and 69365B, Exp 10/15
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 26 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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| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
| Drug | 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 |
|---|---|---|---|---|---|
| Drug | CLASS III | Carisoprodol Tablets, USP, 350 mg recalled by Mylan Institutional, Inc. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Potency & Assay | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories | Watson Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP 350 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Lead & Heavy Metals | Nationwide |
| Drug | CLASS III | Carisoprodol Tablets, USP, 350 mg recalled by West-ward Pharmaceutical | West-ward Pharmaceutical | Other | Nationwide |