CLASS II ONGOING Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Clobazam Tablets 10mg recalled by Micro Labs
Micro Labs is recalling Clobazam Tablets 10mg, distributed nationwide in the US. The recall was initiated on 12 Feb 2024 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-0348-2024
- FDA event ID
- 93975
- Recalling firm
- Micro Labs, Verna, N/A
- Brand
- Clobazam
- Manufacturer
- Micro Labs Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2024
- FDA classified
- 22 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 12 Feb 2024 | Recall initiated by company | |
| 22 Feb 2024 | Classified by FDA | +10 days |
| 28 Feb 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of specification for residual solvents.
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
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Out of specification for residual solvents.
Which lots are affected?
ZOAG043
Where was it sold?
Nationwide in the USA
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 Micro Labs
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Telmisartan Tablets, USP 40mg recalled by Micro Labs | Micro Labs | Potency & Assay | PR, RI, TN |
Other Clobazam recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Clobazam Tablets, 20 mg, CIV recalled by Breckenridge Pharmaceutical | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clobazam Tablets, 10 mg, CIV recalled by Breckenridge Pharmaceutical | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension 2.5 mg/mL recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |