Browse Drug Recalls
2,021 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,021 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 2,021 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 21, 2017 | Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 21, 2017 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Pa... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 21, 2017 | Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in M... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 21, 2017 | Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medli... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 21, 2017 | Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 21, 2017 | Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc.... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... | Class II | Medline Industries Inc |
| Sep 15, 2017 | Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by... | Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which i... | Class I | Baxter Healthcare Corporation |
| Sep 15, 2017 | ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... | Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear)... | Class II | Becton Dickinson & Company |
| Sep 14, 2017 | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien... | CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha... | Class II | Medisca, Inc. |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testo... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Pa... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 5, 2017 | Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... | Class II | Teva Pharmaceuticals USA |
| Aug 23, 2017 | Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| Aug 17, 2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... | Class III | VistaPharm, Inc. |
| Aug 16, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 10, 2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... | Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... | Class II | Premier Pharmacy Labs Inc |
| Aug 7, 2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... | Class I | International Laboratories, Inc. |
| Aug 4, 2017 | Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Ma... | Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% ... | Class II | Degasa Sa De Cv |
| Aug 3, 2017 | Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g)... | Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jel... | Class II | MEDLINE INDUSTRIES INC |
| Jul 17, 2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net W... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methox... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Ne... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bott... | Microbial contamination of non-sterile products: product was found to contain mold, identified as... | Class II | Vi-Jon, Inc. |
| Jul 17, 2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxyci... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 14, 2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 10... | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... | Class II | SCA Pharmaceuticals |
| Jul 5, 2017 | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only... | Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product ca... | Class II | Precision Dose Inc. |
| Jun 28, 2017 | Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only,... | Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being ... | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 23, 2017 | Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml B... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Dr... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Com... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Sl... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 19, 2017 | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, ... | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... | Class II | Apace KY LLC |
| Jun 19, 2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose ... | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... | Class II | Apace KY LLC |
| Jun 12, 2017 | Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. ... | Presence of foreign substance: glass particle | Class II | Vi-Jon, Inc. |
| Jun 9, 2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma 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.