Browse Drug Recalls

37 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 37 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 37 FDA drug recalls.

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DateProductReasonClassFirm
Mar 15, 2021 Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Man... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
May 8, 2017 HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactur... Superpotent Drug: above specification for the assay. Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Apr 20, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Jan 16, 2017 DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for:... Failed Impurities/ Degradation Specifications Class III Vintage Pharmaceuticals LLC dba Qualitest Pharm...
Dec 22, 2016 TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:... Failed Stability Specifications Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
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.
Oct 21, 2015 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m... Failed Stability Specifications: Out of Specification results obtained for preservative butylpara... Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Oct 7, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manu... Presence of Particulate Matter. Class II Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Aug 13, 2015 AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured fo... Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Jul 29, 2015 Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500... Failed Dissolution Specifications Class II Vintage Pharmaceuticals LLC dba Qualitest Pharm...
Jul 20, 2015 ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for... Failed Tablet/Capsule Specifications; report of oversized and discolored tablets Class III Qualitest Pharmaceuticals
Jun 29, 2015 HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3... Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable Class III Qualitest Pharmaceuticals
Jun 18, 2015 Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for... Failed Dissolution Specifications: During routine stability testing at the 12 month time point, ... Class III Qualitest Pharmaceuticals
Mar 25, 2015 PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10... Failed Impurities/Degradation Specifications: A stability lot was out of specification for a know... Class III Qualitest Pharmaceuticals
Feb 23, 2015 PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan H... Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product. Class II Qualitest Pharmaceuticals
Feb 13, 2015 AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32... Failed tablet specifications: One lot was found to contain oversized tablets. Class II Qualitest Pharmaceuticals
Dec 22, 2014 ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL,... Failed Impurities/Degradation Specifications: High out of specification results for the known imp... Class III Qualitest Pharmaceuticals
Sep 11, 2014 MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)... Subpotent; 6 month stability time point Class III Qualitest Pharmaceuticals
Aug 27, 2014 OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Man... Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. Class II Qualitest Pharmaceuticals
Aug 6, 2014 CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingre... Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminop... Class II Qualitest Pharmaceuticals
Aug 6, 2014 CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active i... Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminop... Class II Qualitest Pharmaceuticals
Aug 6, 2014 CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingred... Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminop... Class II Qualitest Pharmaceuticals
Jan 28, 2014 Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ... Failed Impurity/degradation Specification Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Dec 16, 2013 Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) ... Failed impurities/degradation specifications; out of specification for the known impurity 4-chlor... Class III Qualitest Pharmaceuticals
Aug 8, 2013 K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium... LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co... Class II Qualitest Pharmaceuticals
Aug 8, 2013 EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg),... LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co... Class II Qualitest Pharmaceuticals
Apr 19, 2013 GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufac... Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle... Class II Qualitest Pharmaceuticals
Dec 14, 2012 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tabl... Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both... Class I Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Dec 6, 2012 Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged... Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Class I Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Oct 11, 2012 Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured f... Tablet Separation: Possibility of cracked or split coating on the tablets. Class II Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Sep 10, 2012 HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-coun... Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets result... Class I Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Jul 6, 2012 HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg... Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month roo... Class III Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Jul 6, 2012 HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bot... Impurities/Degradation Products: High Out of Specification results for a known impurity resulted ... Class III Vintage Pharmaceuticals LLC DBA Qualitest Pharm...

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.