Tramadol Hydrochloride Tablets USP CIV — Class III drug recall D-0851-2020
Terminated recall by Teva Pharmaceuticals USA, reported 2020-02-26, distributed nationwide. Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain langu
| Recall number | D-0851-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-01-28 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,044,497 bottles |
| Reason classes | labeling |
| NDC | 00093-0058-01, 00093-0058-05 |
| Expiration dates | 2020-01, 2020-02, 2020-03, 2020-04, 2020-05, 2020-06, 2020-07, 2020-08, 2020-09, 2020-12, 2021-01, 2021-02, 2021-03, 2021-04 |
Product
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
Reason for recall
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
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-0851-2020. 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.