CLASS III Drug recall · Reported 27 Mar 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 30 Nov 2012 and the FDA has classified it as Class III.
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-201-2013
- FDA event ID
- 64104
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Nov 2012
- FDA classified
- 15 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 30 Nov 2012 | Recall initiated by company | |
| 15 Mar 2013 | Classified by FDA | +105 days |
| 27 Mar 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 69160A
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from West-ward Pharmaceutical
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| 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 II | Carisoprodol Tablets, USP, 350 mg recalled by West-ward Pharmaceutical | West-ward Pharmaceutical | Packaging Defects | Nationwide |