CLASS III Drug recall · Reported 4 Mar 2020 · FDA Enforcement Report
Tramadol Hydrochloride Tablets, USP, 50 mg recalled
Golden State Medical Supply is recalling Tramadol Hydrochloride Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 12 Feb 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0856-2020
- FDA event ID
- 85008
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Feb 2020
- FDA classified
- 26 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 12 Feb 2020 | Recall initiated by company | |
| 26 Feb 2020 | Classified by FDA | +14 days |
| 4 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Tramadol recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalledTramadol Hydrochloride | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | TraMADol HCl, Packaged as (a) recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |