Recall archive
162 recalls · page 4 of 7
Reported Nov 21, 2018
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals…
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; out-of-specification results for impurities obtained during routine stability testing
FDA (openFDA drug enforcement)
Reported Oct 31, 2018
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
7 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 24, 2018
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
FDA (openFDA drug enforcement)
Reported Oct 10, 2018
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
FDA (openFDA drug enforcement)
Reported Aug 15, 2018
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — API material used in the manufacturing of the product did not receive regulatory approval prior to release.
FDA (openFDA drug enforcement)
Reported Aug 1, 2018
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
8 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 18, 2018
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification…
FDA (openFDA drug enforcement)
Reported May 30, 2018
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand — Failed Stability Specifications
FDA (openFDA drug enforcement)
Reported Mar 28, 2018
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
FDA (openFDA drug enforcement)
Reported Feb 21, 2018
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details · Reason for recall — Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of…
FDA (openFDA drug enforcement)
Reported Feb 14, 2018
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 17, 2018
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during…
FDA (openFDA drug enforcement)
Reported Dec 27, 2017
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
FDA (openFDA drug enforcement)
Reported Dec 20, 2017
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, 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 — Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
FDA (openFDA drug enforcement)
Reported Dec 6, 2017
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Tablet/Capsule Specifications; potential presence of broken tablets.
FDA (openFDA drug enforcement)
Reported Nov 8, 2017
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
FDA (openFDA drug enforcement)
Reported Nov 1, 2017
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Dissolution Specifications: Low out of specification results for dissolution.
FDA (openFDA drug enforcement)
Reported Oct 4, 2017
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the…
FDA (openFDA drug enforcement)
Reported Aug 16, 2017
Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
FDA (openFDA drug enforcement)
Reported Aug 9, 2017
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand — Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 26, 2017
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: 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 test results for related compounds largest unknown impurity.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported May 17, 2017
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Stability Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 22, 2017
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA…
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
FDA (openFDA drug enforcement)
Reported Mar 15, 2017
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
FDA (openFDA drug enforcement)
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