Teva Doxylamine Succinate Tablets Recall: Failed Dissolution Risk
Teva Pharmaceuticals USA recalls 100-count doxylamine succinate/pyridoxine hydrochloride tablets due to failed dissolution specification. This may affect medication effectiveness. Check NDC 0591-2132-01 and lots 100025842, 100028023.
Lower-risk recall
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling 100-count doxylamine succinate and pyridoxine hydrochloride tablets because they failed dissolution tests. This could mean the medication doesn't work as intended, so users should check if they have the recalled batch. Read more at govinfonow.com/recall/35385-teva-doxylamine-succinate-tablets-recall-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35385-teva-doxylamine-succinate-tablets-recall-failed-dissolution-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0461-2022
Cite this page
“Teva Doxylamine Succinate Tablets Recall: Failed Dissolution Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35385-teva-doxylamine-succinate-tablets-recall-failed-dissolution-risk. Based on FDA recall #D-0461-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0461-2022%22&limit=1).
Why it’s dangerous
The tablets failed dissolution tests, meaning the active ingredients may not dissolve properly in the body. This could lead to the medication not working as intended, but it does not cause immediate harm or injury.
Who’s affected
People with prescriptions for this medication who have the specific NDC 0591-2132-01 batch numbers 100025842 or 100028023. Those using the medication as directed are most at risk.
How to tell if you have this one
Check for the NDC code 0591-2132-01 on the bottle label. The batch numbers 100025842 or 100028023 and expiration date of August 2023 are also indicators of the recalled product.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0591-2132-01 and batch numbers 100025842 or 100028023 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0461-2022 (January 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0461-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.