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Browse Drug Recalls

76 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 76 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 76 FDA drug recalls.

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DateProductReasonClassFirm
Sep 5, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... Class II Apotex Corp.
Sep 5, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... Class II Apotex Corp.
May 28, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Ap... Defective Container: This recall is being initiated due to a leaking unit stored horizontally. Class II Apotex Corp.
May 28, 2025 Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. ... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufacture... Lack of Assurance of Sterility Class II Apotex Corp.
Feb 9, 2024 Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... CGMP Deviations: potential presence of Burkholderia cepacia complex Class II Apotex Corp.
Nov 10, 2023 PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 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... Class II Apotex Corp.
May 25, 2023 Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx onl... Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. Class II Golden State Medical Supply Inc.
Mar 1, 2023 Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartr... Class II Apotex Corp.
Dec 21, 2022 Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t... Class III Apotex Corp.
May 3, 2022 Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... Class III Apotex Corp.
Mar 31, 2021 Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiap... Class II Apotex Corp.
Mar 15, 2021 Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Appl... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Nov 17, 2020 ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... Class II Golden State Medical Supply Inc.
Nov 11, 2020 Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... Failed Dissolution Specifications: Out of specification for dissolution. Class II Apotex Corp.
May 27, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable in... Class II Apotex Inc.
Oct 22, 2019 Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf... Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Ato... Class III Apotex Inc.
Sep 24, 2019 Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Mar 1, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Bli... Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. Class II Apotex Inc.
May 31, 2018 Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... Presence of foreign substance: glass particles Class II Apotex Inc.
May 8, 2018 Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Sing... Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency Class I Apotex Inc.
May 8, 2018 Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single... Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency Class I Apotex Inc.
Feb 3, 2017 CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by... Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... Class II Apotex Inc.
Dec 27, 2016 Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ... Superpotent Drug; out of specification results for assay (manufacturer) Class III The Harvard Drug Group
Dec 19, 2016 Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex... Superpotent Drug: Product may not meet specifications throughout shelf life. Class III Apotex Inc.
Dec 14, 2016 Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I... CGMP Deviations Class II Apotex Corp.
Dec 14, 2016 Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In... CGMP Deviations Class II Apotex Corp.
Jan 27, 2016 Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 27, 2016 Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 27, 2016 Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 27, 2016 Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Aug 25, 2015 Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... Lack of Assurance of Sterility: Failed preservative effectiveness testing Class II Apotex Inc.
Aug 17, 2015 Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 cou... Failed Stability Specifications: product may not meet specification limit for assay test. Class II Apotex Inc.
Jul 21, 2015 Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bott... Failed Dissolution Specification: One lot of product did not meet the first stage dissolution spe... Class III Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufacture... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.
May 29, 2015 Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufacture... Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... Class II Apotex Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.