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.

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Date	Product	Reason	Class	Firm
Feb 7, 2018	Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin...	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o...	Class I	Pfizer Inc.
Jan 22, 2018	Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf...	Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol	Class III	Ascent Pharmaceuticals, Inc.
Jan 11, 2018	Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 11, 2018	Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Time-Cap Laboratories, Inc.
Jan 10, 2018	Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit...	CGMP deviations: Ibuprofen is being recalled in response to previous recall	Class II	Spirit Pharmaceuticals, LLC
Jan 9, 2018	Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Jan 9, 2018	Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag...	CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai...	Class II	Marksans Pharma Inc.
Dec 21, 2017	Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Phar...	Failed Content Uniformity Specifications	Class III	Taro Pharmaceuticals U.S.A., Inc.
Dec 15, 2017	Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distribut...	Presence of particulate matter	Class II	Amneal Pharmaceuticals
Nov 19, 2017	Hard Times For Men capsules, packaged in a 23-count box of blister packs cont...	Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredie...	Class I	www.blankterrmall.com
Oct 20, 2017	diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m...	SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent	Class I	Pfizer Inc.
Oct 20, 2017	Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed ...	SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent	Class II	Pfizer Inc.
Oct 6, 2017	No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, D...	Marketed Without an Approved NDA/ANDA	Class II	NEW RELIANCE TRADING, INC.
Sep 25, 2017	Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100...	Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t...	Class III	Amneal Pharmaceuticals, Inc.
Sep 25, 2017	Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-c...	Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t...	Class III	Amneal Pharmaceuticals, Inc.
Sep 20, 2017	Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical...	Cross contamination with other products: traces of Dapsone were found in the finished product.	Class III	Taro Pharmaceuticals U.S.A., Inc.
Sep 14, 2017	Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien...	CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha...	Class II	Medisca, Inc.
Sep 1, 2017	Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu...	Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.	Class II	Pfizer Inc.
Aug 30, 2017	Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only...	Presence of Particulate Matter: glass particulate found in vial	Class I	Pfizer Inc.
Aug 22, 2017	Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ...	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used...	Class II	Pfizer Inc.
Aug 22, 2017	HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c...	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used...	Class II	Pfizer Inc.
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.

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.