CLASS II Drug recall · Reported 27 Mar 2013 · FDA Enforcement Report
Meprobamate; Tablets USP, 400 mg recalled by Watson Laboratories
Watson Laboratories is recalling Meprobamate; Tablets USP, 400 mg, distributed nationwide in the US. The recall was initiated on 8 Feb 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-204-2013
- FDA event ID
- 64312
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Feb 2013
- FDA classified
- 19 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 8 Feb 2013 | Recall initiated by company | |
| 19 Mar 2013 | Classified by FDA | +39 days |
| 27 Mar 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
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
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
Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Meprobamate; Tablets USP, 400 mg recalled?
Yes. Watson Laboratories recalled Meprobamate; Tablets USP, 400 mg on 8 Feb 2013. The recall is Class II and its status is Terminated. Recall number D-204-2013.
Why was it recalled?
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Which lots are affected?
387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14
Where was it sold?
Nationwide and Puerto Rico
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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