Browse Drug Recalls

6,322 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,322 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 6,322 FDA drug recalls.

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DateProductReasonClassFirm
Sep 17, 2026 FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manuf... Lack of Assurance of Sterility Class II Aurolab Trust
Sep 15, 2026 Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.2... Lack of Assurance of Sterility Class II Insight Pharmaceuticals LLC, a Prestige Consume...
Sep 15, 2026 Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.2... Lack of Assurance of Sterility Class II Insight Pharmaceuticals LLC, a Prestige Consume...
Sep 4, 2026 Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials pe... Lack of Assurance of Sterility Class II Pfizer
Aug 20, 2026 Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Di... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 c... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellul... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 11, 2026 Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, R... Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified ... Class I American Regent, Inc.
Jul 29, 2026 CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, St... Lack of assurance of sterility. The recall is due to potential contamination Class II Prestige Brands Holdings
Jul 28, 2026 Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous ... Lack of Assurance of Sterility Class II Regeneron Pharmaceuticals Inc
Jul 14, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 14, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... Lack of Assurance of Sterility Class II Rohto-Mentholatum (Vietnam) Co., Ltd.
Jul 9, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa... Class II CareFusion 213, LLC
Jul 6, 2026 CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Sing... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
Jun 24, 2026 Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, Fo... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intraven... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 24, 2026 Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For... Lack of Sterility Assurance Class II Reliance Life Sciences Private Limited
Jun 11, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopr... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropy... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v is... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 11, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v... Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for furth... Class II CareFusion 213, LLC
Jun 10, 2026 IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Singl... Lack of assurance of Sterility: Class II ACCORD BIOPHARMA INC
Jun 8, 2026 Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only,... Lack of Assurance of Sterility Class II Asclemed USA Inc.
Jun 8, 2026 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL sin... Lack of Assurance of Sterility Class II Asclemed USA Inc.
May 28, 2026 BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v i... Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility:... Class I CareFusion 213, LLC
May 28, 2026 BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-Sterility: Due to presence of Aspergillus penicillioides. Class I CareFusion 213, LLC
May 28, 2026 BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 28, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 18, 2026 PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PR... Lack of Assurance of Sterility Class II PReye LLC
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.

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.