Tramadol Tablets (Golden State) – Incorrect Package Insert (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Golden State Medical Supply Inc.
Lot Codes / Batch Numbers
Lot Numbers: a) GS021259, Exp. Date 11/31/2019, GS021742, GS022074, Exp. 2/29/2020, GS022619, GS022836, 3/31/2020, GS023243, GS023631, Exp. 4/30/2020, GS023869, GS024562, GS025492, Exp. 5/31/2020, GS025184, Exp. 6/30/2020, GS026306, Exp. 9/30/2020, GS026654, Exp.=12/31/2020, GS027566, Exp. 2/28/2020, GS028574, Exp. 4/30/2021, b) GS021570, GS021444, GS021445, GS021443, GS021447, GS021446, 11/31/2019, GS021745, GS021746, GS021744, GS022076, GS022077, GS022078, GS022075, GS021747, GS021748, Exp. 2/29/2020, GS022622, GS022623, GS022624, GS022620, GS022837, GS022838, GS022856, GS022621, Exp. 3/31/2020, GS023029, GS023028, GS023027, Exp. 4/30/2020, GS023958, GS023959, GS023960, GS025045, GS024929, GS025048, GS025047, GS025588, GS025046, Exp. Date 5/31/2020, GS025260, GS025259, Exp.6/30/2020, GS025717, GS025719, GS025718, Exp. 8/31/2020, GS023607, GS026308, GS026309, Exp. 9/30/2020, GS026912, GS026911, GS026910, Exp. 12/31/2020, GS027678, Exp. 2/28/2021, GS027836, Exp. 11/30/2020, GS027570, GS027569, Exp. 2/28/2020, GS027572, GS027571, Exp. 4/30/2021
Products Sold
Lot Numbers: a) GS021259, Exp. Date 11/31/2019; GS021742, GS022074, Exp. 2/29/2020; GS022619, GS022836, 3/31/2020; GS023243, GS023631, Exp. 4/30/2020; GS023869, GS024562, GS025492, Exp. 5/31/2020; GS025184, Exp. 6/30/2020; GS026306, Exp. 9/30/2020; GS026654, Exp.=12/31/2020; GS027566, Exp. 2/28/2020; GS028574, Exp. 4/30/2021; b) GS021570, GS021444, GS021445, GS021443, GS021447, GS021446, 11/31/2019; GS021745, GS021746, GS021744, GS022076, GS022077, GS022078, GS022075, GS021747, GS021748, Exp. 2/29/2020; GS022622, GS022623, GS022624, GS022620, GS022837, GS022838, GS022856, GS022621, Exp. 3/31/2020; GS023029, GS023028, GS023027, Exp. 4/30/2020; GS023958, GS023959, GS023960, GS025045, GS024929, GS025048,GS025047, GS025588, GS025046, Exp. Date 5/31/2020; GS025260, GS025259, Exp.6/30/2020; GS025717, GS025719, GS025718, Exp. 8/31/2020; GS023607, GS026308, GS026309, Exp. 9/30/2020; GS026912, GS026911, GS026910, Exp. 12/31/2020; GS027678, Exp. 2/28/2021; GS027836, Exp. 11/30/2020; GS027570, GS027569, Exp. 2/28/2020; GS027572, GS027571, Exp. 4/30/2021
Golden State Medical Supply Inc. is recalling TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-co due to Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026