Teva Pharmaceuticals USA recalls Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count
Teva Pharmaceuticals recalls 50mg tramadol tablets with incorrect patient instructions that may lead to improper dosing. Affected lots manufactured in Czech Republic for US distribution.
Lower-risk 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.
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What happened, in plain English
Teva Pharmaceuticals is recalling certain 50mg tramadol hydrochloride tablets due to incorrect patient instructions that could lead to improper dosing. This recall affects specific lots of tablets sold in the US. Read more at govinfonow.com/recall/37393-teva-tramadol-50mg-tablets-recall-incorrect-dosing-instructions.
Source Summary by GovInfoNow · govinfonow.com/recall/37393-teva-tramadol-50mg-tablets-recall-incorrect-dosing-instructions · Updated October 5, 2026 · FDA enforcement record: FDA #D-0851-2020
Cite this page
“Teva Tramadol 50mg Tablets Recall: Incorrect Dosing Instructions.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37393-teva-tramadol-50mg-tablets-recall-incorrect-dosing-instructions. Based on FDA recall #D-0851-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0851-2020%22&limit=1).
Why it’s dangerous
The patient leaflets for these specific lots mention a 25mg dosing titration that requires using a scored 50mg tablet. However, the tablets are unscored, so patients might not realize they need to split the tablet for proper dosing.
Who’s affected
Prescription holders of the recalled tramadol tablets in the US. Patients who take the medication as directed without scoring the tablet may be at risk of incorrect dosing.
How to tell if you have this one
Check for 50mg tramadol hydrochloride tablets in 100-count or 500-count bottles with NDC numbers 0093-0058-01 or 0093-0058-05. The lot numbers listed in the recall include specific expiration dates.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your tablets have the NDC numbers 0093-0058-01 or 0093-0058-05 and the specific lot numbers listed in the recall.
Questions people ask
Why is this medication being recalled?
The patient leaflets for these specific lots mention a 25mg dosing titration that requires using a scored 50mg tablet, but the tablets are unscored.
Do I need to stop using these tablets?
No, but you should check if your tablets are in the recalled lots. If they are, you may need to split the tablet for proper dosing as instructed in the patient leaflet.
How can I tell if my tablets are part of this recall?
Check for 50mg tramadol hydrochloride tablets in 100-count or 500-count bottles with NDC numbers 0093-0058-01 or 0093-0058-05 and the specific lot numbers listed in the recall.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0851-2020 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0851-2020 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0851-2020 (January 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0851-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.