CLASS II Drug recall · Reported 29 Jun 2022 · FDA Enforcement Report
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg recalled
SUN Pharmaceutical Industries is recalling Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, distributed nationwide in the US. The recall was initiated on 3 Jun 2022 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-1155-2022
- FDA event ID
- 90340
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2022
- FDA classified
- 22 Jun 2022
- Reported
- 29 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Anxiety & Sleep Medication
Timeline
| 3 Jun 2022 | Recall initiated by company | |
| 22 Jun 2022 | Classified by FDA | +19 days |
| 29 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
Where it was distributed
nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Which lots are affected?
Lot #: MHC1430A, Exp. Date 09/2023
Where was it sold?
nationwide within the United States
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 SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Orally Disintegrating recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Clonazepam Orally Disintegrating Tablets USP, 2 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |