Sun Pharmaceutical Recalls Clonazepam Tablets Due to Cross-Contamination
Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets because routine stability testing detected cross-contamination with clozapine.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. Given the presence of a cross-contamination hazard (clozapine) rather than a purely cosmetic or documentation issue, a score of 2 (Moderate) is appropriate.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 3,516 bottles of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg. The affected product is identified by Lot # AA84106 and has an expiration date of 9/2021. The recall is being conducted because routine stability testing discovered an out-of-specification (OOS) result for the highest unknown impurity, which was later identified as clozapine.
The recall covers products distributed nationwide in the United States. The source text does not specify specific states or distribution channels beyond the nationwide scope. No illnesses or injuries are reported in the source text.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Affected units
- 3,516
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 (2)
- Lot #: AA84106
- Exp 9/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- HighClonazepam Tablets Recalled Due to Manufacturing Defect
FDA (Drugs) · 2022-06-29
- ModerateSun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures
FDA (Drugs) · 2017-05-17
- LowGabapentin Capsules 400 mg Recalled for Cross Contamination
FDA (Drugs) · 2025-04-16
- LowMylan Recalls Clonazepam Tablets Due to Impurity Specification Failure
FDA (Drugs) · 2016-02-10
- ModerateTeva Recalls Clonazepam Tablets Due to Content Uniformity Failure
FDA (Drugs) · 2013-04-10
- LowGabapentin Capsules Recalled for Cross Contamination
FDA (Drugs) · 2025-04-16