Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Apr 13, 2015	Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose via...	Crystallization	Class II	Hospira Inc.
Apr 13, 2015	Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose via...	Crystallization	Class II	Hospira Inc.
Apr 12, 2015	Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx On...	Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil ar...	Class I	Stroheckers Inc Pharmacy
Mar 31, 2015	C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC...	Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as...	Class II	Cody Laboratories, Inc.
Mar 24, 2015	Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Flu...	Failed Content Uniformity Specifications: The product may not meet finished product release speci...	Class III	Nomax Inc
Mar 24, 2015	Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL...	Failed Content Uniformity Specifications: The product may not meet finished product release speci...	Class III	Nomax Inc
Mar 23, 2015	Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
Mar 18, 2015	Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
Mar 6, 2015	MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx onl...	Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect ...	Class I	Hospira Inc.
Feb 25, 2015	Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, M...	Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.	Class II	Noven Pharmaceuticals, Inc.
Feb 12, 2015	Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams ste...	Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene	Class II	Par Pharmaceutical Inc.
Feb 12, 2015	Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,...	Labeling: Illegible label. Writing is rubbing off of labels.	Class III	Nanophase Technologies Corporation
Feb 11, 2015	DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use...	Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may...	Class III	Mylan Institutional LLC
Jan 23, 2015	KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via...	Crystallization	Class II	Hospira Inc.
Jan 23, 2015	KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi...	Crystallization	Class II	Hospira Inc.
Jan 2, 2015	Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syrin...	Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" a...	Class II	SCA Pharmaceuticals
Dec 19, 2014	3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tub...	Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number a...	Class III	3M Company/3m Espe Dental Products
Dec 16, 2014	J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ ...	Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red...	Class II	Jaymac Pharmaceuticals L.L.C.
Dec 15, 2014	Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactu...	Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre...	Class II	Actavis Elizabeth LLC
Dec 15, 2014	Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14...	Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre...	Class II	Actavis Elizabeth LLC
Dec 15, 2014	Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45...	Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre...	Class II	Actavis Elizabeth LLC
Dec 5, 2014	Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand...	Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an i...	Class III	Sandoz Incorporated
Dec 5, 2014	BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactur...	Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or ill...	Class III	Eisai Inc
Dec 4, 2014	Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1...	CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-...	Class III	K C Pharmaceuticals Inc
Dec 4, 2014	Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid...	CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-...	Class III	K C Pharmaceuticals Inc
Dec 4, 2014	Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C...	CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-...	Class III	K C Pharmaceuticals Inc
Dec 4, 2014	Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H...	CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-...	Class III	K C Pharmaceuticals Inc
Nov 25, 2014	Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx...	Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st...	Class III	Hospira Inc.
Nov 10, 2014	Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose con...	Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were inc...	Class II	Baxter Healthcare Corp.
Nov 7, 2014	Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g...	Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ...	Class III	Hospira Inc.
Oct 17, 2014	Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinon...	Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadverten...	Class II	Obagi Medical Products
Oct 10, 2014	Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by ...	Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were pac...	Class II	Contract Packaging Resources Inc.
Oct 7, 2014	ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ...	Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listin...	Class II	Zee Medical Products Inc
Oct 3, 2014	Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-...	Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as...	Class II	Sagent Pharmaceuticals Inc
Sep 12, 2014	Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, R...	Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled roo...	Class II	Mckesson
Sep 8, 2014	Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq...	Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride inject...	Class II	Baxter Healthcare Corp
Aug 28, 2014	Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingr...	Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b...	Class II	Solace International Inc
Aug 28, 2014	Dermatend Original, mole, wart and skin tag remover, For external use only, I...	Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not b...	Class II	Solace International Inc
Aug 19, 2014	Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. ...	Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution te...	Class III	Perrigo Holland Inc
Aug 7, 2014	MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product p...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a p...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. ...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due t...	Class II	New Gpc Inc.
Aug 7, 2014	WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 7, 2014	Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic ...	Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to...	Class II	New Gpc Inc.
Aug 6, 2014	Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white spr...	Microbial Contamination of Non-Sterile Product	Class II	HLI dba Humphreyline Inc
Jul 17, 2014	Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ...	Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m...	Class III	X-Gen Pharmaceuticals Inc.
Jul 8, 2014	VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only...	Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex...	Class III	Pfizer Inc.
Jul 1, 2014	Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa...	Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta...	Class I	American Health Packaging

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.