Browse Drug Recalls

378 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 378 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 378 FDA drug recalls in N/A.

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DateProductReasonClassFirm
Jul 23, 2024 Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 1... Defective container: unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Apr 26, 2024 traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distri... Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count t... Class II Rubicon Research Private Limited
Apr 25, 2024 Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co... Class II FDC Limited
Apr 9, 2024 Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Mar 27, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... CGMP Deviations Class II NATCO Pharma Limited
Mar 23, 2024 Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 23, 2024 Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Feb 12, 2024 Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs... CGMP Deviations: Out of specification for residual solvents. Class II Micro Labs Limited
Feb 9, 2024 Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... Failed Stability Specifications: Out of specification for blend uniformity. Class II Micro Labs Limited
Jan 10, 2024 Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... Lack of Sterility Assurance: Aseptic process simulation failure. Class II BE PHARMACEUTICALS AG
Nov 20, 2023 Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured ... Failed Dissolution Specifications Class III Siegfried Barbera, SL
Aug 23, 2023 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufa... Defective Container: slow leakage under the cap Class III Contract Pharmaceuticals Limited Canada
Aug 14, 2023 Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL ... Failed Impurities/Degradation Specifications Class III Caplin Steriles Limited
Jun 21, 2023 Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... Failed dissolution specification: Out of specification results observed in 24-month long term sta... Class II Dr Reddy's Laboratories Limited
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only,... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only,... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Crit... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufa... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Cri... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civic... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xe... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal C... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Ma... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xe... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manu... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xe... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critica... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cr... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manuf... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cri... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. f... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. f... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xel... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Phar... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufac... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civi... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmac... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.

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.