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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Sep 10, 2018 Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas ---... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- N... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Pow... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 6... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 1... Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes o... Class II Takeda Development Center Americas, Inc.
Sep 10, 2018 Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, H... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL I... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 ... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 6, 2018 Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30... Failed impurities/degradation specifications: Finished product contain a known product impurity a... Class III Par Pharmaceutical, Inc.
Sep 6, 2018 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ... cGMP Deviation Class II Baxter Healthcare Corporation
Sep 6, 2018 Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottl... Failed impurities/ degradation specifications: Out-of-specification results were observed in the ... Class III InvaGen Pharmaceuticals, Inc.
Sep 4, 2018 Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. R... Cross Contamination With Other Products: Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 4, 2018 Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Red... Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl T... Class II Dr. Reddy's Laboratories, Inc.
Aug 31, 2018 Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) pe... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glas... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass or... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, package... CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, ... Class II BioLyte Laboratories, LLC
Aug 30, 2018 Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum,... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Alkano Chemicals, Inc
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 ... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... Class III Pfizer Inc.
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 27, 2018 MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 27, 2018 Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative ... Subpotent Drug: Product may not have the active ingredient present in the bag. Class I QuVa Pharma, Inc.
Aug 27, 2018 Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Sing... Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the... Class I SCA Pharmaceuticals, 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.