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 |
|---|---|---|---|---|
| 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. |
| Apr 28, 2016 | Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distribu... | Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. | Class II | Pfizer Inc. |
| Apr 20, 2016 | SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peopl... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, ... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peopl... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, U... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a ... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count b... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within ... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, r... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFA... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individu... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeli... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The People... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Mar 31, 2016 | ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professio... | Subpotent Drug | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Feb 29, 2016 | col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-... | Superpotent Drug: High out of specification results for assay at the 6 month time point interval. | Class III | Allegiant Health |
| Jan 11, 2016 | Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by... | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ... | Class II | Pfizer Inc. |
| Jan 11, 2016 | Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by... | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ... | Class II | Pfizer Inc. |
| Jan 9, 2016 | Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsule... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsul... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 ca... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 ca... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / ... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 caps... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 4... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules tot... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 cap... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Mar... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 c... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / ... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, LLC |
| Jan 9, 2016 | African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 4... | Marketed Without An Approved NDA/ANDA | Class I | R Thomas Marketing, 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.