CLASS II Drug recall · Reported 28 Dec 2022 · FDA Enforcement Report
Oxcarbazepine Tablets 600mg recalled by Sun Pharmaceutical Industries
SUN Pharmaceutical Industries is recalling Oxcarbazepine Tablets 600mg, distributed nationwide in the US. The recall was initiated on 1 Dec 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-0085-2023
- FDA event ID
- 91311
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Oxcarbazepine
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2022
- FDA classified
- 19 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 1 Dec 2022 | Recall initiated by company | |
| 19 Dec 2022 | Classified by FDA | +18 days |
| 28 Dec 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance
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
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of foreign substance
Which lots are affected?
a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
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 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| 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 |
Other Oxcarbazepine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS I | Oxcarbazepine Tablets, 300 mg per carton (10 recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxcarbazepine Tablets, 300 mg recalled by Caraco PharmaceuticalOxcarbazepine | Caraco Pharmaceutical Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | OXcarbazepine Tablet, 600 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |