Tramadol Hydrochloride Tablets — Class II drug recall D-0878-2023
Terminated recall by The Harvard Drug Group, reported 2023-07-05, distributed nationwide. Packaging defect: blister packaging inadequately sealed.
| Recall number | D-0878-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, La Vergne, TN, United States |
| Recall initiated | 2023-06-16 |
| Classified | 2023-06-26 |
| Reported by FDA | 2023-07-05 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 3,876 cartons |
| Reason classes | packaging |
| NDC | 00904-7179-61 |
| Lot numbers | M04343 |
| Expiration dates | 2024-04 |
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 for recall
Packaging defect: blister packaging inadequately sealed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0878-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.