Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2018 | Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central D... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 20, 2018 | Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, H... | Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tabl... | Class II | Hetero Labs Limited Unit V |
| Aug 20, 2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... | Class II | RemedyRepack Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 15, 2018 | Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Preferred Pharmaceuticals, Inc |
| Aug 14, 2018 | Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... | Supterpotent Drug | Class II | Mckesson Corporation |
| Aug 14, 2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 13, 2018 | Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: ... | Presence of Foreign Substance: Product complaint was received of metal contaminant observed in on... | Class II | Lupin Pharmaceuticals Inc. |
| Aug 10, 2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville... | Incorrect Product Formulation | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 10, 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 3260... | Lack of Process Controls | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 10, 2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tro... | Lack of Process Controls | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 7, 2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 5... | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged l... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Aug 6, 2018 | Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(ND... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, R... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(ND... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, ... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Taked... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 3, 2018 | Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Na... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, ... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decon... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, D... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing 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.