Lower riskDrug recall · FDA · Published July 6, 2020
Sun Pharmaceutical Clonazepam Tablets Recall: Cross Contamination Risk
Sun Pharmaceutical recalls 0.125 mg Clonazepam orally disintegrating tablets due to cross contamination with clozapine during stability testing. Affected lots may pose health risks.
“Sun Pharmaceutical Clonazepam Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36959-sun-pharmaceutical-clonazepam-tablets-recall-cross-contamination-risk. Based on FDA recall #D-1445-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1445-2020%22&limit=1).
The FDA announced on July 6, 2020, that Sun Pharmaceutical Industries Inc. is recalling Clonazepam Orally Disintegrating Tablets due to cross-contamination with clozapine. The agency classified the recall as Class III.
The recall stems from cross-contamination with other products, where an unknown impurity later identified as clozapine was discovered during routine stability testing. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Sun Pharmaceutical has 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include the August 3, 2026, Sun Pharmaceutical Carbamazepine Tablets Recall and the June 17, 2026, Sun Pharmaceutical Perampanel 6mg Tablets Recall. Additional recent recalls of similar products include the November 21, 2025, Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall, the April 27, 2026, Golden State Medical Supply Primidone Tablets Recall, and the June 4, 2026, Annora Pharma Lacosamide Tablets Recall.
How to tell if you have this one
Check for the product name 'Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle' with manufacturer Sun Pharmaceutical Industries, Inc. and lot number AA84106.
Brand
Sun Pharmaceutical
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number AA84106 on the packaging of the recalled Clonazepam tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall indicates cross contamination with clozapine during testing, but the product is not yet confirmed unsafe for use. Affected lots should be checked.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1445-2020 (July 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1445-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.