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 |
|---|---|---|---|---|
| Nov 30, 2016 | MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Sta... | Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active... | Class I | MS Bionic |
| Nov 23, 2016 | Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count b... | Marketed without an approved NDA/ANDA for which safety and efficacy has not been established. | Class I | Jeffreys Drug Store |
| Nov 13, 2016 | Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, M... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence ... | Class I | Ultimate Body Tox |
| Oct 28, 2016 | Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle | Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (... | Class I | Love My Tru Body |
| Sep 23, 2016 | Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-f... | Non-Sterility: failed sterility test result. | Class I | Guardian Pharmacy Services |
| Sep 8, 2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Singl... | Defective delivery system: detached needles on the syringe in the kit. | Class I | Novo Nordisk Inc |
| Sep 2, 2016 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottl... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only,... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. | Class I | United Exchange Corporation |
| Sep 2, 2016 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx ... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Aug 19, 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister... | Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl... | Class I | Impax Laboratories, Inc. |
| Aug 16, 2016 | Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 ... | Non Sterility; contaminated with Klebsiella pneumoniae | Class I | Sperian Eye & Face Protection, Inc |
| Aug 4, 2016 | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing... | Presence of particulate matter: Confirmed customer report for the presence of particulate matter ... | Class I | Hospira Inc., A Pfizer Company |
| Aug 1, 2016 | Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and ... | Non-Sterility; microbial contamination identified as Bacillus circulans | Class I | Town and Country Compounding and Consultation S... |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia ce... | Class I | Sage Products LLC |
| Jul 25, 2016 | Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) ... | Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia | Class I | US Compounding Inc |
| Jul 21, 2016 | Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx O... | Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlargi... | Class I | Arbor Pharmaceuticals Inc. |
| Jul 15, 2016 | Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint ... | Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia | Class I | The Harvard Drug Group |
| May 12, 2016 | Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| May 12, 2016 | Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| May 12, 2016 | Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| May 12, 2016 | Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| Apr 29, 2016 | BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it... | Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. | Class I | Making It a Lifestyle |
| Apr 29, 2016 | BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifes... | Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. | Class I | Making It a Lifestyle |
| Apr 2, 2016 | Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, ... | Non-sterility - presence of bacteria confirmed by outside laboratory after day 14. | Class I | Complete Pharmacy and Medical Solutions LLC |
| Mar 30, 2016 | PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... | Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case... | Class I | QuVa Pharma, Inc. |
| Mar 25, 2016 | CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... | Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine | Class I | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun... | Non-Sterility: fungal contamination due to leaking containers. | Class I | B. Braun Medical Inc |
| Mar 23, 2016 | Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... | Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. | Class I | Hospira Inc. |
| Mar 18, 2016 | 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL),... | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Class I | Hospira Inc. |
| Mar 9, 2016 | Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manu... | Presence of Particulate Matter: particulate matter identified as glass in one vial. | Class I | Teva Pharmaceuticals USA |
| Feb 11, 2016 | Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, t... | Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of m... | Class I | Pharmakon Pharmaceuticals |
| Jan 21, 2016 | Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Singl... | Presence of Particulate Matter: identified as a cloth fiber. | Class I | Baxter Healthcare Corp. |
| Jan 21, 2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... | Presence of Particulate Matter: identified as cardboard. | Class I | Baxter Healthcare Corp. |
| Jan 21, 2016 | CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose... | Presence of Particulate Matter: identified as dried skin. | Class I | Baxter Healthcare Corp. |
| Jan 15, 2016 | Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manuf... | Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. | Class I | Master Herbs, Inc./Li |
| Jan 9, 2016 | Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed b... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 12... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsul... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsul... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distrib... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distribute... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marke... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 3... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box /... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 4... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / ... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Mar... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 cap... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, 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.