Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Apr 26, 2023	Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 m...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only,...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Ste...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufac...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutan...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufac...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3....	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Int...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 coun...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed ...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, D...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Dis...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured ...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, ...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distr...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Ak...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, Fo...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Ak...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distribute...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured b...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tub...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Apr 26, 2023	Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, pack...	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Class II	Akorn, Inc.
Feb 23, 2023	Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op...	Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo...	Class II	Teva Pharmaceuticals USA Inc
Feb 21, 2023	Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f...	Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan...	Class III	Padagis US LLC
Feb 15, 2023	Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One...	Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro...	Class III	AVEVA Drug Delivery Systems, Inc.
Feb 15, 2023	Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One...	Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro...	Class III	AVEVA Drug Delivery Systems, Inc.
Feb 2, 2023	Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai...	Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.	Class III	Advantice Health, Llc
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 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 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 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 27, 2022	Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad...	Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.	Class III	Jubilant Cadista Pharmaceuticals, Inc.
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.
Dec 12, 2022	Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu...	Failed Impurities/Degradation Specifications: Failure observed in related substance testing durin...	Class II	Lupin Pharmaceuticals Inc.
Nov 2, 2022	Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut...	cGMP deviation: discontinue of stability support for product.	Class II	Direct Rx
Oct 13, 2022	Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-...	Failed Stability Specifications	Class III	Aadi Bioscience
Sep 16, 2022	Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx...	CGMP deviations: Out of specification results obtained during routine stability testing for ethan...	Class II	Novartis Pharmaceuticals Corporation
Sep 14, 2022	Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ...	Failed Stability Specifications: Out of specification results reported at 12-month stability test...	Class III	Dr. Reddy's Laboratories, Inc.
Aug 8, 2022	Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials,...	Identification of an unknown impurity at the 12-month stability point. Further investigation has ...	Class III	Akorn, Inc
Jul 22, 2022	Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom...	Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for...	Class III	Teva Pharmaceuticals USA Inc
Jul 7, 2022	Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050...	Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.	Class II	Apotex Corp.
Jun 29, 2022	Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O...	Superpotent Drug: Out of specification assay result was obtained during stability testing.	Class II	Teva Pharmaceuticals USA Inc
Jun 27, 2022	Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D...	Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti...	Class II	SUN PHARMACEUTICAL INDUSTRIES 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.