RecallCheckr

Apotex Corp. recalls

9 recalls on record · FDA

Every recall we have on record for Apotex Corp., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.

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Health Serious

Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by:…

Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

Apotex Corp. Apr 22, 2026
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Health Serious

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only,…

Lack of Assurance of Sterility

Apotex Corp. Mar 25, 2026
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Health Serious

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10…

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Apotex Corp. Oct 8, 2025
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Health Serious

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex…

Lack of Assurance of Sterility

Apotex Corp. Jul 2, 2025
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Health Serious

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex…

Lack of Assurance of Sterility

Apotex Corp. Jul 2, 2025
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Health Serious

Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#:…

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp. Dec 6, 2023
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Health Serious

Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#:…

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp. Dec 6, 2023
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Health Serious

Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle,…

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp. Dec 6, 2023
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Health Serious

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper…

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

Apotex Corp. Mar 15, 2023
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