Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 13, 2022 | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured ... | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was print... | Class III | GlaxoSmithKline LLC |
| Apr 29, 2022 | Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25... | Mislabeling: The active ingredient list on the label does not match the product's actual ingredie... | Class III | Eco Lips, Inc |
| Apr 13, 2022 | Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box cont... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 12, 2022 | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), pac... | Labeling: Missing label on the vial | Class I | Mylan Pharmaceuticals Inc |
| Apr 5, 2022 | Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pe... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class II | Cardinal Health Inc. |
| Apr 5, 2022 | Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Pr... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class I | Cardinal Health Inc. |
| Apr 5, 2022 | Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose P... | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... | Class II | Cardinal Health Inc. |
| Apr 1, 2022 | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... | Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... | Class III | The Ritedose Corporation |
| Mar 21, 2022 | The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (5... | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Pep... | Class II | Revive Personal Products Company |
| Mar 11, 2022 | Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit... | Labeling: Label Mix-Up | Class II | DASH Pharmaceuticals LLC |
| Mar 8, 2022 | Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 17... | Super Potent and Failed Reconstitution Time | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc... | Class I | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 2, 2022 | HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 4... | Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol a... | Class II | Vi-Jon, Inc. |
| Feb 7, 2022 | 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 M... | Labeling - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Feb 7, 2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by:... | Labeling - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Feb 3, 2022 | Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose ... | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... | Class I | STAQ Pharma, Inc. |
| Feb 3, 2022 | HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Do... | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... | Class I | STAQ Pharma, Inc. |
| Jan 26, 2022 | ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered In... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured b... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuati... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: A... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactu... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amnea... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx onl... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Man... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tab... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lup... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufa... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby La... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Heal... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
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.