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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.