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 |
|---|---|---|---|---|
| Oct 19, 2013 | Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specia... | Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold,... | Class I | Specialty Medicine Compounding Pharmacy, P.C. |
| Oct 18, 2013 | Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-pre... | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in th... | Class I | Hospira Inc. |
| Oct 15, 2013 | Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Deliver... | Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot... | Class I | B. Braun Medical Inc |
| Oct 10, 2013 | Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, w... | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... | Class I | Pure Edge Nutrition |
| Oct 10, 2013 | Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count ... | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... | Class I | Pure Edge Nutrition |
| Oct 10, 2013 | Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, ... | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... | Class I | Pure Edge Nutrition |
| Oct 10, 2013 | Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaVi... | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... | Class I | Pure Edge Nutrition |
| Oct 10, 2013 | Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www... | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... | Class I | Pure Edge Nutrition |
| Oct 10, 2013 | Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.Bell... | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... | Class I | Pure Edge Nutrition |
| Oct 7, 2013 | Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules. | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | Class I | B @ B Trade Inc. |
| Oct 7, 2013 | Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgel... | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | Class I | B @ B Trade Inc. |
| Oct 7, 2013 | Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules. | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | Class I | B @ B Trade Inc. |
| Sep 27, 2013 | Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 caps... | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingred... | Class I | Haute Health, LLC |
| Sep 27, 2013 | PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and ... | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredie... | Class I | Haute Health, LLC |
| Sep 27, 2013 | Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 1... | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredie... | Class I | Haute Health, LLC |
| Sep 16, 2013 | 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., L... | Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochlor... | Class I | Hospira, Inc. |
| Sep 6, 2013 | Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottl... | Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact ... | Class I | Altaire Pharmaceuticals, Inc. |
| Aug 30, 2013 | Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx onl... | Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as... | Class I | Hospira Inc. |
| Aug 29, 2013 | Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-u... | Presence of Particulate Matter; Glass particulates observed in vials | Class I | Cubist Pharmaceuticals, Inc. |
| Aug 14, 2013 | 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in... | Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil | Class I | Fabscout Entertainment, Inc |
| Aug 14, 2013 | PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsu... | Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil | Class I | Fabscout Entertainment, Inc |
| Aug 14, 2013 | Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet She... | Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil | Class I | Fabscout Entertainment, Inc |
| Aug 12, 2013 | J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 ho... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Jack Rabbit, Inc |
| Aug 9, 2013 | CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% ... | Non Sterility: Microbial contamination | Class I | Specialty Compounding, LLC |
| Aug 5, 2013 | Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear s... | Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-d... | Class I | Bethel Nutritional Consulting, Inc |
| Aug 5, 2013 | Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powde... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desme... | Class I | Bethel Nutritional Consulting, Inc |
| Aug 1, 2013 | BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bo... | Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making i... | Class I | CTV Best Group |
| Jul 31, 2013 | B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, ... | Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclare... | Class I | Healthy Life Chemistry Inc dba Purity First |
| Jul 31, 2013 | Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Ch... | Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this produ... | Class I | Healthy Life Chemistry Inc dba Purity First |
| Jul 22, 2013 | Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle ... | Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17... | Class I | Mira Health Products Ltd. |
| Jul 22, 2013 | B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count ... | Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine whic... | Class I | Mira Health Products Ltd. |
| Jul 22, 2013 | METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic ... | Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid an... | Class I | Mira Health Products Ltd. |
| Jul 19, 2013 | Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round pl... | Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed ... | Class I | Myson Corporation, Inc. |
| Jul 19, 2013 | Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 cap... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plasti... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhanceme... | Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed ... | Class I | Myson Corporation, Inc. |
| Jul 19, 2013 | Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle,... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 19, 2013 | Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bo... | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmet... | Class I | Herbal Give Care Llc |
| Jul 12, 2013 | 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira ... | Presence of particulate matter: visible free floating and partially embedded particulate matter i... | Class I | Hospira Inc. |
| Jul 12, 2013 | 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira ... | Presence of particulate matter: visible free floating and partially embedded particulate matter i... | Class I | Hospira Inc. |
| Jun 27, 2013 | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 1... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Fabscout Entertainment, Inc |
| Jun 27, 2013 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Fabscout Entertainment, Inc |
| Jun 17, 2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... | Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... | Class I | Advance Pharmaceutical Inc |
| Jun 11, 2013 | Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. ... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibut... | Class I | Bethel Nutritional Consulting, Inc |
| May 31, 2013 | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, ... | Non-Sterility: The firm's contract testing laboratory found sterility failures. | Class I | Abrams Royal Pharmacy |
| May 28, 2013 | Methylprednisolone 80mg/ml (PF) 10ml, Main Street Compounding Pharmacy, 126 E... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class I | Main Street Family Pharmacy, LLC |
| May 28, 2013 | Methylprednisolone 100mg/ml, 10ml, Main Street Compounding Pharmacy, 126 East... | The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... | Class I | Main Street Family Pharmacy, LLC |
| May 25, 2013 | Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 ... | Presence of Particulate Matter: Glass particulate matter was observed in a retention sample durin... | Class I | Fresenius Kabi USA, LLC |
| May 20, 2013 | Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL S... | Presence of Particulate Matter: Found during examination of retention samples. | Class I | Sandoz Incorporated |
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.