Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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-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 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 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 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 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 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.
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 6, 2017 ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and... Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Class I Andropharm, LLC
Jun 6, 2017 ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsu... Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. Class I Andropharm, LLC
Jun 5, 2017 Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two pla... Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the... Class III L. Perrigo Company
Jun 5, 2017 EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... Class I Bristol-myers Squibb Company
Jun 1, 2017 Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... Class II American Pharmaceutical Ingredients LLC
May 25, 2017 BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx... Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bott... Class I AstraZeneca Pharmaceuticals, LP
May 18, 2017 Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx on... Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually ... Class II Forest Laboratories, LLC
May 5, 2017 AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... Class III Ascend Laboratories LLC
Apr 20, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class I C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... Class I C. O. Truxton
Apr 17, 2017 Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgel... Subpotent: This product is being recalled due to low out of specification assay results at the 9... Class III P & L Development, LLC
Apr 17, 2017 Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pi... Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel.... Class III Fagron, Inc
Apr 13, 2017 Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.000000000000... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Apr 13, 2017 Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HP... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... Class II PharMedium Services, 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.