Browse Drug Recalls
17,539 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,539 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 17,539 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2024 | Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC... | Discoloration: Dotted and yellow spots on tablets | Class II | Aurobindo Pharma USA Inc. |
| Apr 24, 2024 | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vial... | Presence of Foreign Substance: This oil based product may contain trace amounts of water for inje... | Class II | SOMERSET THERAPEUTICS LLC |
| Apr 24, 2024 | Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC ... | Discoloration: Dotted and yellow spots on tablets | Class II | Aurobindo Pharma USA Inc. |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 23, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, N... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count... | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... | Class II | EPI Health, LLC |
| Apr 23, 2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... | Lack of Assurance of Sterility: Complaints of syringe breakage | Class II | Regeneron Pharmaceuticals Inc |
| Apr 22, 2024 | Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, dis... | Marketed Without An Approved NDA/ANDA | Class I | Stop Clopez Corp |
| Apr 22, 2024 | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle... | Failed Release Testing: Out of specification for particulate matter test. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 20, 2024 | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate | Class I | Revive Rx LLC dba Revive Rx Pharmacy |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: S... | Out of specification for assay | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 19, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx ... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 19, 2024 | FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips pe... | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... | Class II | Nomax Inc |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor ... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... | Out of Specification for active ingredient | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... | Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... | Class II | ARG Laboratories, Inc. |
| Apr 17, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 12, 2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jar... | cGMP Deviations | Class II | Dercher Enterprises, Inc., DBA Gordon Laboratories |
| Apr 10, 2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solut... | Subpotent Drug | Class II | Imprimis NJOF, LLC |
| Apr 10, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL S... | Out of specification for assay | Class III | Imprimis NJOF, LLC |
| 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), 15 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), 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), 30 mg tablets, packaged in 30 count bottles, RX only,... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 8, 2024 | Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... | Sub-potent Drug; powder discoloration associated with decreased potency | Class I | Dr. Reddy's Laboratories, Inc. |
| Apr 8, 2024 | Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... | Sub-potent Drug; powder discoloration associated with decreased potency | Class I | Dr. Reddy's Laboratories, Inc. |
| Apr 2, 2024 | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... | Class III | X-Gen Pharmaceuticals Inc. |
| Apr 2, 2024 | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... | Class III | X-Gen Pharmaceuticals Inc. |
| Mar 29, 2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents:... | CGMP Deviations | Class II | HONEYWELL INC |
| Mar 28, 2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 28, 2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | Class I | AvKARE |
| Mar 27, 2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... | CGMP Deviations | Class II | NATCO Pharma Limited |
| Mar 27, 2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottl... | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month... | Class III | Esperion |
| Mar 26, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 26, 2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed i... | Class II | Cipla USA, Inc. |
| Mar 25, 2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Mar 25, 2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufa... | Failed Impurities/Degradation Specifications | Class III | Novitium Pharma LLC |
| 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. |
| 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. |
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.