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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

BluePoint Duloxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: December 3, 2024
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Summary

Amerisource Health Services LLC has recalled 69,967 bottles of Duloxetine (duloxetine) Delayed-Release Capsules, sold under the BluePoint Laboratories brand. The recall includes 20 mg, 30 mg, and 60 mg strengths in various bottle sizes. This medication is being recalled because testing found an impurity called N-nitroso-duloxetine at levels higher than the recommended safety limits. Consumers should speak with their doctor or pharmacist before they stop taking this medication, as the risks of suddenly stopping treatment may outweigh the risks of the impurity.

Risk

N-nitroso-duloxetine is a type of nitrosamine, which is classified as a probable human carcinogen. Exposure to these impurities above safety levels over a long period of time may increase the risk of cancer.

What You Should Do

  1. This recall affects BluePoint Laboratories brand Duloxetine (duloxetine) capsules in 20 mg, 30 mg, and 60 mg strengths, packaged in 30, 60, or 1,000-count bottles.
  2. Check your prescription bottle for NDC codes 68001-413-06, 68001-414-04, 68001-414-08, or 68001-415-08 and lot numbers with expiration dates ranging from November 2024 through August 2025. See the Affected Products section below for the full list of affected codes.
  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 Amerisource Health Services LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions 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: Duloxetine Delayed-Release Capsules, USP (20 mg)by BluePoint Laboratories
Variants: 20 mg, 60 count bottles
Lot Numbers:
DT2023001A (Exp Jan 31, 2025)
DT2023009A (Exp Jan 31, 2025)
NDC:
68001-413-06

Manufactured by Aurobindo Pharma Limited for BluePoint Laboratories.

Product: Duloxetine Delayed-Release Capsules, USP (30 mg)by BluePoint Laboratories
Variants: 30 mg, 30 count bottles, 1,000 count bottles
Lot Numbers:
DT3023019B (Exp 01/31/2025)
DT3023020A (Exp 01/31/2025)
DTB23098A (Exp 08/31/2025)
NDC:
68001-414-04
68001-414-08

Manufactured by Aurobindo Pharma Limited for BluePoint Laboratories.

Product: Duloxetine Delayed-Release Capsules, USP (60 mg)by BluePoint Laboratories
Variants: 60 mg, 1,000 count bottle
Lot Numbers:
DT6022159A (Exp 11/30/2024)
DT6022167A (Exp 11/30/2024)
DT6022168A (Exp 11/30/2024)
DT6023034A (Exp 12/31/2024)
DT6023050A (Exp 01/31/2025)
DT6023051A (Exp 01/31/2025)
DT6023063A (Exp 01/31/2025)
DT6023067A (Exp 01/31/2025)
DT6023073A (Exp 02/28/2025)
DT6023072A (Exp 02/28/2025)
NDC:
68001-415-08

Manufactured by Aurobindo Pharma Limited for BluePoint Laboratories.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95849
Status: Active
Manufacturer: Amerisource Health Services LLC
Sold By: Retail Pharmacies
Manufactured In: India, United States
Units Affected: 3 products (37,916 bottles; 23,490 bottles; 8,561 bottles)
Distributed To: Pennsylvania, Ohio, Puerto Rico

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.