FDA Drug recall D-0878-2023
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd
- FDA Drug
- Class II
- terminated
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd by The Harvard Drug Group, citing packaging defect: blister packaging inadequately sealed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0878-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-06-16 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Reason
Packaging defect: blister packaging inadequately sealed.
Identifiers
| code_info | Lot #: M04343, Exp. 04/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0878-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.