Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 10, 2014 | LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... | Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... | Class I | Hospira Inc. |
| Jul 1, 2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| Jul 1, 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| Jun 25, 2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Ph... | Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold co... | Class I | Pharmacy Creations |
| Jun 17, 2014 | Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (15... | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... | Class I | Hospira Inc. |
| Jun 2, 2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... | Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... | Class I | Alexion Pharmaceuticals, Inc. |
| May 28, 2014 | del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 28, 2014 | adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 28, 2014 | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 28, 2014 | LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 12, 2014 | COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vi... | Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic c... | Class I | Bristol-Meyers Squibb |
| May 12, 2014 | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... | Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes | Class I | Baxter Healthcare Corp. |
| May 5, 2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei ... | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... | Class I | Eugene Oregon, Inc. |
| May 5, 2014 | MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Spr... | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... | Class I | Eugene Oregon, Inc. |
| May 5, 2014 | Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang P... | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... | Class I | Eugene Oregon, Inc. |
| Apr 30, 2014 | Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boost... | Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Li... | Class I | Bacai Inc. Dba Ky Duyen House |
| Apr 21, 2014 | Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (2... | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... | Class I | Hospira Inc. |
| Apr 21, 2014 | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Ph... | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Class I | Pharmakon Pharmaceuticals |
| Apr 21, 2014 | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Class I | Pharmakon Pharmaceuticals |
| Apr 21, 2014 | Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL... | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Class I | Pharmakon Pharmaceuticals |
| Apr 18, 2014 | 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-do... | Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, ... | Class I | Hospira Inc. |
| Apr 17, 2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... | Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. | Class I | Cubist Pharmaceuticals, Inc. |
| Apr 15, 2014 | Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured f... | Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and ... | Class I | Sung Soo Kim |
| Apr 9, 2014 | THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Coun... | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. | Class I | Nature's Universe |
| Apr 2, 2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administr... | Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during ... | Class I | Hospira Inc. |
| Mar 28, 2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongw... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineerin... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orl... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orland... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los ... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los... | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 28, 2014 | MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Sp... | Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... | Class I | Nova Products, Inc. |
| Mar 26, 2014 | Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per... | Superpotent Drug: Product contains twice the stated amount of midazolam. | Class I | Pharmakon Pharmaceuticals |
| Mar 25, 2014 | MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged ... | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER... | Class I | New Life Nutritional Center |
| Mar 25, 2014 | New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product i... | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER... | Class I | New Life Nutritional Center |
| Mar 25, 2014 | Esmeralda, bottle contains 30 Softgels, product is packaged in a white plasti... | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER... | Class I | New Life Nutritional Center |
| Mar 14, 2014 | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/via... | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. | Class I | Shire Human Genetic Therapies, Inc. |
| Mar 13, 2014 | REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los hue... | Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. | Class I | Pain Free By Nature |
| Mar 6, 2014 | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a... | Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg ca... | Class I | Pfizer Us Pharmaceutical Group |
| Mar 6, 2014 | Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottl... | Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and ide... | Class I | Greenstone Llc |
| Feb 14, 2014 | CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals... | Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrullin... | Class I | Medisca Inc |
| Feb 14, 2014 | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratorie... | Presence of Particulate Matter: During a review of retain samples, the firm found a glass particu... | Class I | Ben Venue Laboratories Inc |
| Feb 11, 2014 | Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl... | Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag ... | Class I | Baxter Healthcare Corp. |
| Jan 24, 2014 | Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKn... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, suppl... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed ... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cang... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by My... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, dis... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-d... | Class I | MyNicNaxs, 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.