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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

Hetero Labs, Ltd. - Unit III: Aripiprazole Tablets Recalled Due to Ingredient Specification Failure

Agency Publication Date: March 13, 2018
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Summary

Hetero Labs is recalling 3,000 bottles of Aripiprazole (aripiprazole) Tablets, USP, 10 mg, manufactured for Camber Pharmaceuticals. The recall was issued because a production lot was made with an active pharmaceutical ingredient that failed to meet quality and purity specifications. These 30-count bottles were distributed exclusively in New Jersey.

Risk

Medications that do not meet chemical specifications may not work as intended or could potentially cause unexpected side effects due to the manufacturing deviation. No specific injuries have been reported to date.

What You Should Do

  1. Check your prescription bottle to see if you have Aripiprazole Tablets, USP, 10 mg (NDC 31722-827-30) in 30-count bottles.
  2. Look for lot numbers ARI17089 or ARI17090 with an expiration date of 5/2019 located on the product label.
  3. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking the medication or switch to a different lot.
  4. Return any unused product from the affected lots to your pharmacy to receive a refund.
  5. Contact the manufacturer, Hetero Labs, or the distributor, Camber Pharmaceuticals, for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Aripiprazole Tablets, USP, 10 mg (30-count bottle)
Model:
NDC 31722-827-30
Recall #: D-0594-2018
Lot Numbers:
ARI17089 (Exp. 5/2019)
ARI17090 (Exp. 5/2019)
Date Ranges: Exp. 5/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78809
Status: Resolved
Manufacturer: Hetero Labs, Ltd. - Unit III
Sold By: Camber Pharmaceuticals, Inc.; Pharmacies in New Jersey
Manufactured In: India
Units Affected: 3000 bottles
Distributed To: New Jersey

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.