Recall archive
162 recalls · page 6 of 7
Reported Nov 5, 2014
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
FDA (openFDA drug enforcement)
Reported Aug 20, 2014
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details · Reason for recall — Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for…
FDA (openFDA drug enforcement)
Reported Aug 6, 2014
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability…
FDA (openFDA drug enforcement)
Reported Jul 23, 2014
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva…
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 Impurities/Degradation Specifications: out of specification impurity test results.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 16, 2014
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details · Reason for recall — Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a…
FDA (openFDA drug enforcement)
Reported Jul 2, 2014
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during…
FDA (openFDA drug enforcement)
Reported Jun 25, 2014
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ferring Pharmaceuticals Inc.
Matched: Brand · Product details — Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the…
FDA (openFDA drug enforcement)
Reported Jun 4, 2014
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Non-sterility: due to a failed sterility test
FDA (openFDA drug enforcement)
Reported May 28, 2014
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported May 21, 2014
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
3 more products in this recall
FDA (openFDA drug enforcement)
Reported May 7, 2014
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Legacy Pharmaceutical Packaging
Matched: Brand · Product details — Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual…
FDA (openFDA drug enforcement)
Reported May 7, 2014
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 9, 2014
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details · Reason for recall — Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg &…
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 26, 2014
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.McKesson Packaging Services
Matched: Product details — Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
FDA (openFDA drug enforcement)
Reported Mar 12, 2014
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than…
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2014
Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
FDA (openFDA drug enforcement)
Reported Feb 12, 2014
Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 29, 2014
Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Failed Stability Specifications: this product is below specification for preservative content.
FDA (openFDA drug enforcement)
Reported Jan 8, 2014
Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Presence of Precipitate; precipitation of drug product
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 1, 2014
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem…
FDA (openFDA drug enforcement)
Reported Nov 27, 2013
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
FDA (openFDA drug enforcement)
Reported Sep 11, 2013
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
FDA (openFDA drug enforcement)
Reported Sep 4, 2013
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva…
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 — Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not…
FDA (openFDA drug enforcement)
Reported Aug 14, 2013
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg…
3 more products in this recall
FDA (openFDA drug enforcement)
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