CLASS III Drug recall · Reported 5 Aug 2020 · FDA Enforcement Report
Clonazepam Orally Disintegrating Tablets, USP, 125 mg recalled
Sun Pharmaceutical Industries is recalling Clonazepam Orally Disintegrating Tablets, USP, 125 mg, distributed nationwide in the US. The recall was initiated on 6 Jul 2020 and the FDA has classified it as Class III.
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-1445-2020
- FDA event ID
- 85995
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Jul 2020
- FDA classified
- 30 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 6 Jul 2020 | Recall initiated by company | |
| 30 Jul 2020 | Classified by FDA | +24 days |
| 5 Aug 2020 | 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
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
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
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
Where it was distributed
Nationwide USA
Questions about this recall
Is Clonazepam Orally Disintegrating Tablets, USP, 125 mg recalled?
Yes. Sun Pharmaceutical Industries recalled Clonazepam Orally Disintegrating Tablets, USP, 125 mg on 6 Jul 2020. The recall is Class III and its status is Terminated. Recall number D-1445-2020.
Why was it recalled?
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Which lots are affected?
Lot #: AA84106, Exp 9/2021
Where was it sold?
Nationwide 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Sun Pharmaceutical Industries
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | Sun Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Clonazepam recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 25 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets, USP, 125 mg, C-IV recalledClonazepam | Endo USA | Labeling Errors | Nationwide |
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |