Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ... Failed Stability Specifications: Out of specification test results for viscosity was identified a... Class III Akorn, Inc.
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 27, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... Class II Amerisource Health Services LLC
Jan 20, 2023 Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... Subpotent Drug: Low assay result observed during long-term stability testing. Class III Lupin Pharmaceuticals Inc.
Jan 17, 2023 Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 17, 2023 Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 M... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Urban Electric Power
Jan 17, 2023 Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Urban Electric Power
Jan 17, 2023 Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 16, 2023 Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord He... Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a... Class II Preferred Pharmaceuticals, Inc.
Jan 13, 2023 FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free ... Short Fill: Underfilled units. Class III OurPharma LLC
Jan 13, 2023 Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 13, 2023 S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Ste... Short Fill Class II Nephron Sc Inc
Jan 13, 2023 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine,... Short Fill Class II Nephron Sc Inc
Jan 12, 2023 Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 12, 2023 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Onl... CGMP Deviations: potential for trace amounts of product carryover. Class II Nephron Sc Inc
Jan 12, 2023 Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for:... Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack t... Class II Accord Healthcare, Inc.
Jan 11, 2023 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 10... Failed Dissolution Specifications: This recall is being initiated in support of the recall by the... Class II Amerisource Health Services LLC
Jan 10, 2023 Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle... CGMP Deviations: initiated due to violations of CGMP manufacturing practices Class II Consolidated Chemical, Inc
Jan 10, 2023 Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Sai... CGMP Deviations: initiated due to violations of CGMP manufacturing practices Class II Consolidated Chemical, Inc
Jan 6, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syri... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for... Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package inse... Class III MACLEODS PHARMA USA, INC
Jan 4, 2023 SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... Class III Intersect ENT, Inc.
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTAB... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC

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.