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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Actavis Doxylamine and Pyridoxine Tablets Recalled for Failed Dissolution

Agency Publication Date: January 28, 2022
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Summary

Teva Pharmaceuticals USA has voluntarily recalled 6,205 100-count bottles of Actavis Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets (10 mg/10 mg), a prescription medication used to treat nausea and vomiting during pregnancy. The recall was issued because the tablets failed dissolution testing, meaning the active ingredients may not be released into the body at the required rate. This defect could make the medication less effective at managing symptoms. No injuries or incidents have been reported to date. Consumers should consult their healthcare provider or pharmacist regarding their treatment and any remaining medication.

Risk

Because the tablets failed to meet dissolution standards, the active ingredients may not be properly absorbed by the patient. This could result in ineffective treatment for nausea and vomiting.

What You Should Do

  1. This recall affects Actavis Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets (10 mg/10 mg) sold in 100-count bottles with NDC 0591-2132-01.
  2. Check the bottle label for lot numbers 100025842 or 100028023, both of which have an expiration date of 08/2023.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets (100-count bottle)
Variants: 10 mg/10 mg, Delayed-Release
Lot Numbers:
100025842 (Exp 08/2023)
100028023 (Exp 08/2023)
NDC:
0591-2132-01

Quantity: 6,205 bottles. Manufactured by Actavis Laboratories FL, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89422
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 6205 100-count bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.