Browse Drug Recalls
399 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 399 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 399 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 24, 2017 | Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufac... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Feb 3, 2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by... | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... | Class II | Apotex Inc. |
| Dec 29, 2016 | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : ... | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of p... | Class III | Hetero Drugs Ltd. - Unit 1 |
| Dec 19, 2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex... | Superpotent Drug: Product may not meet specifications throughout shelf life. | Class III | Apotex Inc. |
| Nov 22, 2016 | Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed... | Labeling: Label Mix Up- Incorrect back label applied to the product. | Class III | Les Emballages Knowlton Inc. |
| Oct 19, 2016 | Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Man... | Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial ... | Class II | Inventia Healthcare Private Limited |
| Sep 7, 2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Vari... | Defective Delivery System: Incorrect type of syringe found in commercially distributed administra... | Class III | Biocompatibles U.K., Ltd. |
| 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 |
| Mar 11, 2016 | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J... | Labeling: Label Error on Declared Strength | Class III | Jubilant Draximage Inc |
| Feb 25, 2016 | Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per car... | Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as... | Class III | Torrent Pharmaceuticals Limited |
| Feb 11, 2016 | Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only... | Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceedi... | Class II | Sun Pharma Global Fze |
| Oct 20, 2015 | Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... | Labeling: Incorrect or Missing Lot AND/OR Exp Date. | Class III | Teva Pharmaceutical Industries |
| 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 |
| 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 | 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 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 | 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 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 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 | Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF ... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Aug 25, 2015 | Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... | Lack of Assurance of Sterility: Failed preservative effectiveness testing | Class II | Apotex Inc. |
| Aug 5, 2015 | Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd ... | Failed Impurities/Degradation Specifications: Out of specification results for impurities testing... | Class III | Taro Pharmaceuticals, Inc. |
| Jul 13, 2015 | Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by P... | Subpotent drug | Class III | Perrigo Israel Pharmaceuticals |
| May 29, 2015 | Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| May 29, 2015 | Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufacture... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| May 29, 2015 | Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufacture... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| May 29, 2015 | Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bo... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| Apr 24, 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Cipla Limited |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... | Subpotent drug | Class III | Apotex Inc. |
| Feb 12, 2015 | Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, ... | CGMP Deviations: Product excipient was not re-tested at the appropriate date. | Class III | Apotex Inc. |
| Jan 21, 2015 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distr... | Presence of Particulate Matter: lot is not meeting the specification limit for number of particle... | Class II | Sun Pharma Global Fze |
| Jan 21, 2015 | Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Ma... | Failed Dissolution Specifications: 6 month time point. | Class II | Sun Pharma Global Fze |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex Inc. |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex Inc. |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex Inc. |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex Inc. |
| Sep 26, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles... | Failed Dissolution Specifications; 12 month stability time point | Class II | Sun Pharma Global Inc. |
| Apr 8, 2014 | Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfi... | Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discover... | Class II | Pfizer Inc. |
| Feb 14, 2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 m... | Presence of Particulate Matter: Potential for small black particles to be present in individual v... | Class II | Agila Specialties Private Ltd. |
| Jul 17, 2013 | Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by A... | Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitri... | Class II | Apotex Inc. |
| Jun 25, 2013 | Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx o... | Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), there... | Class II | Apotex Inc |
| Sep 5, 2012 | Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (rec... | Lack of Assurance of Sterility; container closure issues with the bulk batch. | Class II | F. Hoffmann-LaRoche Ltd. |
| Apr 30, 2012 | Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL... | Presence of Particulate Matter: Lots identified in this recall notification may contain small pa... | Class II | Apotex Inc. |
| Mar 9, 2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX... | Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir ... | Class II | Aurobindo Pharma LTD |
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.