CLASS II Drug recall · Reported 15 Jan 2014 · FDA Enforcement Report
Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories
Watson Laboratories is recalling Carisoprodol Tablets, USP, CIV, 350 mg, distributed nationwide in the US. The recall was initiated on 23 Dec 2013 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-397-2014
- FDA event ID
- 67200
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2013
- FDA classified
- 6 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 23 Dec 2013 | Recall initiated by company | |
| 6 Jan 2014 | Classified by FDA | +14 days |
| 15 Jan 2014 | 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; metal particulates were visually observed in the tablets.
Product as listed by the FDA
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Which lots are affected?
Lot # 244152A, exp 01/15.
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.
More recalls from Watson Laboratories
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Next Choice" One Dose Emergency Contraceptive recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg recalled | Watson Laboratories | 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 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 |
| Drug | CLASS II | Carisoprodol Tablets, USP, 350 mg recalled by West-ward Pharmaceutical | West-ward Pharmaceutical | Packaging Defects | Nationwide |