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.

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DateProductReasonClassFirm
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.