The Recall Desk
ModerateFDA (Drugs)·D-0461-2022·Announced 2022-02-09

Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution

Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride delayed-release tablets because dissolution test results for the active ingredient fall below specification limits, which may affect drug effectiveness.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect (failed dissolution specification) that represents a quality/efficacy issue rather than an acute safety threat. No deaths, serious injuries, or hospitalizations are reported, and the risk is related to potential therapeutic failure rather than direct harm.

Plain-English summary

Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottles (NDC 0591-2132-01) distributed nationwide. The recall affects approximately 6205 bottles from lot numbers 100025842 and 100028023, with an expiration date of 08/2023.

The product is being recalled because dissolution test results for the active ingredient are below specification limits. Dissolution refers to how quickly and completely a tablet breaks down and releases its active ingredients in the body. When dissolution is below specification, the drug may not be absorbed properly or may not achieve its intended therapeutic effect.

This product is a prescription medication used for nausea and vomiting during pregnancy. Patients should consult their healthcare provider or pharmacist before discontinuing use or replacing the medication. The FDA and Teva Pharmaceuticals USA advise consumers who have this product to contact their pharmacist or physician for further guidance.

The recalled product

Product
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
Brand
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Tablet
Hazard
  • dissolution-failure
  • efficacy-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot# 100025842
  • 100028023
  • Exp Date 08/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category