Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 12, 2026 | Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distribut... | Lack of Assurance of Sterility | Class II | Spectra Medical Devices, Llc |
| May 8, 2026 | cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), R... | Lack of Assurance of Sterility | Class II | UCB Biosciences Inc. |
| Apr 27, 2026 | Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle... | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll... | Class II | Oasis Medical, Inc. |
| Apr 24, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Apr 23, 2026 | iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made... | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... | Class II | Thea Pharma, Inc. |
| Apr 23, 2026 | Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (1... | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... | Class II | Thea Pharma, Inc. |
| Apr 22, 2026 | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... | Lack of assurance of Sterility: potential product contamination | Class II | CareFusion 213, LLC |
| Apr 22, 2026 | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl ... | Lack of assurance of Sterility: potential product contamination | Class II | CareFusion 213, LLC |
| Apr 21, 2026 | Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in F... | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... | Class II | Alcon Research LLC |
| Apr 21, 2026 | GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: ... | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr... | Class II | Alcon Research LLC |
| Apr 20, 2026 | Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile... | Lack of Assurance of Sterility | Class II | SCOPE HEALTH |
| Apr 17, 2026 | FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nas... | Lack of Assurance of Sterility | Class II | Harrow Eye LLC |
| Apr 6, 2026 | DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 6, 2026 | DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchan... | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 2, 2026 | Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Via... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials,... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL)... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Pre... | Lack of Assurance of Sterility | Class II | Huons Co., Ltd. |
| Apr 2, 2026 | Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 2, 2026 | 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Bra... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 2, 2026 | LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medica... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 2, 2026 | DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical... | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is re... | Class II | B BRAUN MEDICAL INC |
| Apr 1, 2026 | EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MED... | Lack of Assurance of Sterility | Class II | International Medication Systems Ltd. |
| Mar 25, 2026 | Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polye... | Lack of Assurance of Sterility | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 20, 2026 | Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, F... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 20, 2026 | norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, ... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 20, 2026 | norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP,... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 20, 2026 | Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection US... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 20, 2026 | Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 17, 2026 | CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... | Lack of Assurance of Sterility | Class II | Chiesi USA, Inc. |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 13, 2026 | Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1... | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for ... | Class II | Cipla USA, Inc. |
| Mar 13, 2026 | Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Singl... | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for ... | Class II | Cipla USA, Inc. |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL i... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL f... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 m... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL f... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL i... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 1... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL),... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 6, 2026 | Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL ... | Lack of Assurance of Sterility | Class II | PAYLESS COMPOUNDERS, LLC |
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.