CLASS III Drug recall · Reported 19 Mar 2014 · FDA Enforcement Report
Carisoprodol Tablets, USP, 350 mg recalled by Mylan Institutional, Inc.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of (10 cards of each), distributed nationwide in the US. The recall was initiated on 28 Jan 2014 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-1155-2014
- FDA event ID
- 67393
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jan 2014
- FDA classified
- 12 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Jan 2014 | Recall initiated by company | |
| 12 Mar 2014 | Classified by FDA | +43 days |
| 19 Mar 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/degradation Specification
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
Where it was distributed
US: Nationwide
Questions about this recall
Why was it recalled?
Failed Impurity/degradation Specification
Which lots are affected?
Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
Where was it sold?
US: 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 Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other Carisoprodol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Carisoprodol Tablets, USP, 350 mg recalled by West-ward Pharmaceutical | West-ward Pharmaceutical | Packaging Defects | Nationwide |