TRAMADOL HYDROCHLORIDE Tablets — Class III drug recall D-0856-2020
Terminated recall by Golden State Medical Supply Inc., reported 2020-03-04, distributed nationwide. Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain langu
| Recall number | D-0856-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golden State Medical Supply Inc., Camarillo, CA, United States |
| Recall initiated | 2020-02-12 |
| Classified | 2020-02-26 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2023-04-04 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 60429-0588-01, 60429-0588-05 |
| Expiration dates | 2020-02-28, 2020-02-29, 2020-03-31, 2020-04-30, 2020-05-31, 2020-06-30, 2020-08-31, 2020-09-30, 2020-11-30, 2020-12-31, 2021-02-28, 2021-04-30 |
Product
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
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-0856-2020. 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.