Browse Drug Recalls
18,008 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,008 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 18,008 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 25, 2022 | fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| 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 22, 2022 | SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack wi... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil. | Class I | Distributor RFR, LLC. |
| Jul 21, 2022 | SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per ... | Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil. | Class I | Ultra Supplement LLC |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 20, 2022 | Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo... | Labeling: Label Error on Declared Strength | Class III | AVKARE Inc. |
| Jul 19, 2022 | Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: St... | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets | Class II | Strides Pharma Inc. |
| Jul 19, 2022 | Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ.... | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Jul 19, 2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM B... | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Jul 18, 2022 | Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... | Failed Dissolution Specifications | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 18, 2022 | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... | Failed dissolution specifications. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 15, 2022 | SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl ... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/f... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), D... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz)... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) ... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), G... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) ... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) pe... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F... | CGMP Deviations; | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled ... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon F... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flav... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutio... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 14, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Jul 13, 2022 | Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per g... | Presence of particulate matter: particulate identified as a beetle. | Class I | Pfizer Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g... | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Uns... | Class II | Tolmar, Inc. |
| Jul 11, 2022 | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Us... | Defective Container: Tube split from side seam | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, M... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 8, 2022 | Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.2... | Labeling: Missing label: the product tube was missing a label and contained a different formulation. | Class III | The Procter & Gamble Company |
| 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. |
| Jul 5, 2022 | Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 m... | Labeling: Missing label: Label missing from some prefilled pens. | Class I | Mylan Pharmaceuticals Inc |
| Jun 30, 2022 | HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
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.