Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 11, 2016 | aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topi... | CGMP Deviations | Class II | The Aloe Source |
| May 11, 2016 | VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | tabcin NOCHE; Capsules,12-count box, UPC 501008485033 | CGMP Deviations | Class II | Profarma Distributors LLC |
| Apr 6, 2016 | Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for:... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Apr 6, 2016 | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-51... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Apr 4, 2016 | Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-c... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 11, 2016 | Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packag... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 11, 2016 | Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-coun... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 11, 2016 | Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packag... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 11, 2016 | Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15... | CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. | Class III | Lupin Pharmaceuticals Inc. |
| Mar 11, 2016 | Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-coun... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 19, 2016 | Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactur... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Limited |
| Feb 19, 2016 | Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactu... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin Limited |
| Feb 5, 2016 | Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Package... | CGMP Deviations: Cylinders filled using out of date gauges. | Class III | Medical Park Homecare, Inc |
| Nov 29, 2015 | Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, In... | cGMP Deviations; trailer may not have met GMP requirements prior to filling | Class II | AGA Gas Inc |
| Oct 15, 2015 | Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF ... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bo... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel c... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bo... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, B... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 5... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL)... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Sep 25, 2015 | FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... | Class III | Boehringer Ingelheim Roxane Inc |
| Sep 25, 2015 | FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... | Class III | Boehringer Ingelheim Roxane Inc |
| Sep 16, 2015 | UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution... | CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. | Class III | Praxair Inc. |
| Sep 16, 2015 | UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribu... | CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. | Class III | Praxair Inc. |
| Jul 29, 2015 | Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: W... | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. | Class II | Wockhardt Usa Inc. |
| Jul 29, 2015 | Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: ... | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. | Class II | Wockhardt Usa Inc. |
| Jul 10, 2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Pac... | cGMP Deviations | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jul 9, 2015 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only... | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... | Class II | Mutual Pharmaceutical Company, Inc. |
| Jul 9, 2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5... | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... | Class II | Mutual Pharmaceutical Company, Inc. |
| Jul 9, 2015 | Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5... | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... | Class II | Mutual Pharmaceutical Company, Inc. |
| Jun 5, 2015 | Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... | CGMP Deviation: Poor container closure of the bulk storage container | Class III | Geritrex Corp |
| Jun 1, 2015 | Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-4... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-1... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11);... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| Jun 1, 2015 | Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II | American Health Packaging |
| May 22, 2015 | Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA L... | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... | Class II | Blenheim Pharmacal, 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.