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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

Apotex Paroxetine Hydrochloride Tablets Recalled for Impurity Specifications

Agency Publication Date: November 27, 2023
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Summary

Apotex Corp. is recalling 112,865 units of Paroxetine Hydrochloride Tablets (the generic version of the antidepressant Paxil) in 10 mg, 20 mg, 30 mg, and 40 mg strengths. The recall was issued because laboratory testing found levels of an impurity (Amadori Glucose adduct) that exceeded approved specifications. The affected products were distributed nationwide in various bottle sizes ranging from 30 to 1,000 tablets.

Risk

Taking medication that does not meet purity standards could expose patients to unintended degradation products, which may potentially impact the safety or effectiveness of the treatment.

What You Should Do

  1. This recall affects Apotex brand Paroxetine Hydrochloride Tablets USP in 10 mg, 20 mg, 30 mg, and 40 mg strengths, packaged in 30-count, 100-count, and 1,000-count bottles.
  2. Identify affected bottles by checking the NDC numbers printed on the label, which include 60505-0097-1, 60505-0097-2, 60505-0097-4 (10 mg); 60505-0083-2, 60505-0083-4 (20 mg); 60505-0084-1, 60505-0084-2, 60505-0084-4 (30 mg); and 60505-0101-4 (40 mg). 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 the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Paroxetine Hydrochloride Tablets USP (10 mg)
Variants: 10 mg, Tablet
Lot Numbers:
RV2376 (Exp. 08/2024)
RV2377 (Exp. 08/2024)
RV2379 (Exp. 08/2024)
RV2380 (Exp. 08/2024)
RV2375 (Exp. 08/2024)
NDC:
60505-0097-1
60505-0097-2
60505-0097-4

Quantity affected: 34,392 units.

Product: Paroxetine Hydrochloride Tablets USP (20 mg)
Variants: 20 mg, Tablet
Lot Numbers:
RV2384 (Exp. 08/2024)
RV2385 (Exp. 08/2024)
RV2396 (Exp. 08/2024)
RV2397 (Exp. 08/2024)
NDC:
60505-0083-2
60505-0083-4

Quantity affected: 48,623 units.

Product: Paroxetine Hydrochloride Tablets USP (30 mg)
Variants: 30 mg, Tablet
Lot Numbers:
RV8686 (Exp. 08/2024)
RX0119 (Exp. 08/2024)
RV2254 (Exp. 08/2024)
NDC:
60505-0084-1
60505-0084-2
60505-0084-4

Quantity affected: 25,776 units.

Product: Paroxetine Hydrochloride Tablets USP (40 mg)
Variants: 40 mg, Tablet
Lot Numbers:
RV0131 (Exp. 08/2024)
RV2387 (Exp. 08/2024)
RV2389 (Exp. 08/2024)
RW3296 (Exp. 08/2024)
RV2388 (Exp. 08/2024)
NDC:
60505-0101-4

Quantity affected: 4,074 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93353
Status: Active
Manufacturer: Apotex Corp.
Sold By: Pharmacies
Manufactured In: Canada
Units Affected: 4 products (34,392; 48,623; 25,776; 4,074)
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.