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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.