Browse Drug Recalls
1,681 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,681 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 1,681 FDA drug recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 14, 2018 | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) I... | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | Class III | United Therapeutics Corp. |
| Aug 14, 2018 | Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... | Failed Impurities/Degradation Specifications; out of specification results for related compound p... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| 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 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, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| 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 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 13, 2018 | Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Livin... | Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of... | Class I | Living Well Remedies, LLC |
| 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 | 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 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 | 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 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 | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 3260... | Lack of Process Controls | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 9, 2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90... | Defective Container: Customer complaints of punctures in the bottle. | Class III | Orexigen Therapeutics, Inc. |
| 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 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, 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, 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 | Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle... | Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-... | Class III | Akorn, Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| 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 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| 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 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, 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 | 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 | 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 | 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 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 3, 2018 | CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster Pharmaceuticals LLC |
| Aug 3, 2018 | CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin z... | Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazolin... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodi... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bot... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benza... | 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 Extra Moisturizing Nasal Spray (Oxymetazolin... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100... | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... | Class I | Westminster Pharmaceuticals LLC |
| Aug 3, 2018 | Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) ... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tub... | 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 |
| 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 | 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 | 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 | 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 |
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.