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.

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DateProductReasonClassFirm
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.