Browse Drug Recalls
1,018 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,018 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 1,018 FDA drug recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Sep 27, 2016 | Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0... | Subpotent Drug; Ethinyl Estradiol | Class III | Par Pharmaceutical, Inc. |
| Sep 15, 2016 | PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx o... | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expi... | Class III | Pfizer Inc. |
| Sep 9, 2016 | Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For... | Failed Impurities/Degradations Specifications; Out of specification results for two known degrada... | Class III | Pfizer Inc. |
| Jun 2, 2016 | Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05)... | Crystallization; complaints received by the manufacturer of crystals forming in product | Class III | Exact-Rx Inc |
| May 28, 2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 ... | Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydro... | Class III | Par Pharmaceutical |
| May 26, 2016 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Ka... | Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc py... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| May 17, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... | Class III | Clinique International |
| May 17, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... | Class III | Clinique International |
| May 17, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... | Class III | Clinique International |
| May 17, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... | Class III | Clinique International |
| May 17, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... | Class III | Clinique International |
| May 17, 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... | Class III | Clinique International |
| May 12, 2016 | Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| May 12, 2016 | Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| May 12, 2016 | Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom Inc. |
| May 12, 2016 | Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared si... | Class I | SOS Telecom 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.