Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2016 | UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: M... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Aug 8, 2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. ... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bay... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg i... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by:... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Jul 29, 2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufacture... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured ... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 7, 2016 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Heal... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jun 17, 2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... | CGMP Deviations | Class II | Teva North America |
| Jun 1, 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... | Class III | Aidarex Pharmaceuticals LLC |
| May 18, 2016 | Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compoun... | cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration | Class III | Attix Pharmaceuticals Inc |
| May 11, 2016 | 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 | CGMP Deviations | Class II | Profarma Distributors LLC |
| 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 |
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.