Clobazam tablets recalled nationwide for residual solvent deviation
Micro Labs Limited is recalling 24,768 bottles of Clobazam 10mg tablets nationwide due to out-of-specification residual solvents. Patients should contact their healthcare provider for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a manufacturing deviation involving out-of-specification residual solvents. While residual solvents represent a potential quality and safety concern, no illnesses, injuries, or hospitalizations have been reported in the source text. Per the severity rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
Micro Labs Limited is recalling Clobazam (clobazam) 10mg tablets, a prescription benzodiazepine. The recalled product consists of 24,768 bottles distributed nationwide in the United States with lot code ZOAG043. The medication was manufactured by Micro Labs Limited in Goa, India, for Micro Labs USA, Inc., and distributed under NDC 42571-315-01 and related package codes.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the medication was found to contain residual solvents at levels that exceed FDA specifications. Residual solvents are chemical substances used during the manufacturing process and must remain within approved limits to ensure product quality and safety.
Patients taking Clobazam from the recalled lot should contact their healthcare provider or pharmacist for guidance regarding continued seizure management and options for obtaining replacement medication.
The recalled product
- Product
- CLOBAZAM (CLOBAZAM)
- Brand
- CLOBAZAM
- Manufacturer
- Micro Labs Limited
- Category
- Drug — Prescription Tablet
- Hazard
- residual-solvents
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ZOAG043
UPCs (2)
- 0342571316013
- 0342571315016
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CLOBAZAM
- HighClobazam tablets recalled for contamination with foreign tablets
FDA (Drugs) · 2025-01-22
- HighClobazam Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-01-15
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27