Recall archive
162 recalls · page 2 of 7
Reported Mar 15, 2023
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
FDA (openFDA drug enforcement)
Reported Mar 8, 2023
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Product details — Packaging defect: observed packaging defect, blister packaging inadequately sealed.
FDA (openFDA drug enforcement)
Reported Sep 21, 2022
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug…
FDA (openFDA drug enforcement)
Reported Sep 7, 2022
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product · Product details · Reason for recall — CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin…
FDA (openFDA drug enforcement)
Reported Aug 17, 2022
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA Inc.
Matched: Brand — Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
FDA (openFDA drug enforcement)
Reported Aug 10, 2022
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Dissolution Specifications: below specification limits for dissolution.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 3, 2022
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — Superpotent Drug: Out of specification assay result was obtained during stability testing.
FDA (openFDA drug enforcement)
Reported Jun 29, 2022
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
FDA (openFDA drug enforcement)
Reported Jun 15, 2022
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
FDA (openFDA drug enforcement)
Reported Jun 8, 2022
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc.,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
FDA (openFDA drug enforcement)
Reported May 4, 2022
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — cGMP Deviations
FDA (openFDA drug enforcement)
Reported Apr 20, 2022
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Product was found to contain silica and iron oxide
FDA (openFDA drug enforcement)
Reported Feb 23, 2022
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CooperSurgical, Inc.
Matched: Product details — Non-sterility
FDA (openFDA drug enforcement)
Reported Feb 9, 2022
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 26, 2022
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the…
FDA (openFDA drug enforcement)
Reported Jan 19, 2022
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Lack of Assurance of Sterility
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 29, 2021
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Subpotent
FDA (openFDA drug enforcement)
Reported Nov 24, 2021
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Labelling: Incorrect Exp. Date
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 27, 2021
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 8, 2021
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 25, 2021
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Lack of Assurance of Sterility
18 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 14, 2021
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details · Reason for recall — Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis…
FDA (openFDA drug enforcement)
Reported May 26, 2021
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Lack of Assurance of Sterility
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 24, 2021
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
FDA (openFDA drug enforcement)
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