Browse Drug Recalls
1,749 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,749 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 1,749 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jan 24, 2014 | Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distribu... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, dist... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs,... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Anoth... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 13, 2014 | PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distribute... | Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, N... | Class I | HUMAN SCIENCE FOUNDATION |
| Jan 10, 2014 | DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, ... | Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the... | Class I | Hospira Inc. |
| Jan 9, 2014 | SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bay... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc.... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also ... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manuf... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Jan 9, 2014 | MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Po... | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... | Class I | Schindele Enterprises dba Midwest Wholesale |
| Dec 23, 2013 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose... | Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass co... | Class I | Hospira Inc. |
| Dec 23, 2013 | Burn 7 Capsules, supplied in 30 capsules bottle | Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 diet... | Class I | Deseo Rebajar |
| Dec 19, 2013 | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis | Class I | Abrams Royal Pharamacy |
| Dec 12, 2013 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... | Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo... | Class I | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 10, 2013 | Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscor... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphth... | Class I | Slim Beauty USA |
| Dec 10, 2013 | Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Dome... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphth... | Class I | Slim Beauty USA |
| Dec 10, 2013 | Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutram... | Class I | Slim Beauty USA |
| Nov 21, 2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX... | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due t... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical 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.