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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

Apotex Inc.: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Agency Publication Date: September 3, 2014
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Affected Products

Product: Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

Lot # 2A001, Exp. 01/15 Lot # 2A002, Exp. 01/15 Lot # 2C003, Exp. 03/15 Lot # 2F005, Exp. 06/15 Lot # 2G006, Exp. 07/15

Lot Numbers:
2A001
2A002
2C003
2F005
2G006
Product: PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15

Lot Numbers:
2A001
2C002
Product: Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

Lot # 2A002, Exp. 01/15 Lot # 2A003, Exp. 01/15 Lot # 2C004, Exp. 03/15 Lot # 2C005, Exp. 03/15 Lot # 2E008, Exp. 05/15 Lot # 2F009, Exp. 06/15 Lot # 2F010, Exp. 06/15 Lot # 2H011, Exp. 08/15 Lot # 2H012, Exp. 08/15 Lot # 2H013, Exp. 0815

Lot Numbers:
2A002
2A003
2C004
2C005
2E008
2F009
2F010
2H011
2H012
2H013
Product: Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3

Lot # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15

Lot Numbers:
2C002
2H004
2H006
Product: PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3

Lot # 2F004, Exp. 06/15

Lot Numbers:
2F004
Product: PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3

Lot # 2E001; Exp. 05/15

Lot Numbers:
2E001
Product: PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3

Lot # 2ZP7113, Exp. 08/15

Lot Numbers:
2ZP7113
Product: PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3

Lot # 2ZP5499, Exp. 02/15

Lot Numbers:
2ZP5499
Product: PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3

Lot # 2ZP3908, Exp. 05/15

Lot Numbers:
2ZP3908

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68967
Status: Resolved
Manufacturer: Apotex Inc.
Manufactured In: Canada
Units Affected: 13,429 bottles

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.

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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 · 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.