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.
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
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.
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.
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.
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.
Look for the NDC code 0591-2132-01 and batch numbers 100025842 or 100028023 on the bottle.
The tablets failed dissolution tests, meaning the active ingredients may not dissolve properly in the body, which could affect medication effectiveness.
Check for the NDC code 0591-2132-01 and batch numbers 100025842 or 100028023 on the bottle label.
The recall does not specify a remedy, so contact your healthcare provider for advice on whether to continue using the medication.
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0461-2022 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0461-2022 from Teva Pharmaceuticals USA. 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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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.
