Browse Drug Recalls
1,034 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,034 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 1,034 FDA drug recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 22, 2017 | No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala,... | Marketed Without an Approved NDA/ANDA | Class II | Shata Trading, Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 3, 2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. | Class I | Amneal Pharmaceuticals of New York, LLC |
| Jul 12, 2017 | Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... | CGMP Deviations: Firm failed to control impurity for color change at the API stage. | Class III | Pfizer Inc. |
| Jun 16, 2017 | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Ma... | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contai... | Class II | Time-Cap Laboratories, Inc. |
| May 17, 2017 | Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle... | Presence of Foreign Substance: potential presence of plastic particles. | Class II | X-Gen Pharmaceuticals Inc. |
| Apr 17, 2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgel... | Subpotent: This product is being recalled due to low out of specification assay results at the 9... | Class III | P & L Development, LLC |
| Apr 17, 2017 | EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,10... | CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. | Class II | Syntho Pharmaceuticals, Inc. |
| Apr 17, 2017 | EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, table... | CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. | Class II | Syntho Pharmaceuticals, Inc. |
| Apr 3, 2017 | ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-08... | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... | Class II | Medisca, Inc. |
| Apr 3, 2017 | ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100... | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... | Class II | Medisca, Inc. |
| Apr 3, 2017 | ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 gram... | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... | Class II | Medisca, Inc. |
| Apr 3, 2017 | ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b... | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... | Class II | Medisca, Inc. |
| Mar 28, 2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... | Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 17, 2017 | Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx on... | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be cont... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 7, 2017 | MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign lang... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign lang... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreig... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in ... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Tiger King tablets, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign lan... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign l... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Indian God Lotion Spray Bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate... | Class III | A&H Focal Inc. |
| Mar 7, 2017 | Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign lan... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in f... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign lang... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 2, 2017 | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A... | Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonid... | Class II | Fougera Pharmaceuticals Inc. |
| Feb 16, 2017 | HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets,... | cGMP deviations - presence of rubber particles found loose in the bulk product. | Class II | Allegiant Health |
| Feb 13, 2017 | PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TO... | Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. | Class III | Colgate Palmolive Co |
| Feb 8, 2017 | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC... | Presence of Particulate Matter | Class I | X-Gen Pharmaceuticals Inc. |
| Nov 22, 2016 | PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... | Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. | Class III | Pfizer Inc. |
| Nov 7, 2016 | LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, R... | Superpotent | Class II | Pfizer Inc. |
| Nov 2, 2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/... | Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... | Class II | Fallon Wellness Pharmacy, L.L.C. |
| Nov 2, 2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL ... | Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... | Class II | Fallon Wellness Pharmacy, L.L.C. |
| Oct 5, 2016 | Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx... | Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the ... | Class II | Par Pharmaceutical, Inc. |
| Sep 27, 2016 | Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02... | Subpotent Drug; Ethinyl Estradiol | Class III | Par Pharmaceutical, Inc. |
| Sep 27, 2016 | Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablet... | Subpotent Drug; Ethinyl Estradiol | Class III | Par Pharmaceutical, Inc. |
| Sep 27, 2016 | Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, ... | Subpotent Drug; Ethinyl Estradiol | Class III | Par Pharmaceutical, Inc. |
| Sep 27, 2016 | Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol table... | Subpotent Drug; Ethinyl Estradiol | Class III | Par Pharmaceutical, Inc. |
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.