Recall archive
162 recalls · page 3 of 7
Reported Mar 10, 2021
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, 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 — Chemical contamination; Unknown brown residue adhering to the inside of one vial.
FDA (openFDA drug enforcement)
Reported Mar 3, 2021
Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per…
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: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of…
14 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 25, 2020
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand — Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
FDA (openFDA drug enforcement)
Reported Nov 18, 2020
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 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 — Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
FDA (openFDA drug enforcement)
Reported Oct 7, 2020
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Stability Specifications: Below specification result for buprenorphine release rate.
FDA (openFDA drug enforcement)
Reported Sep 16, 2020
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 19, 2020
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
FDA (openFDA drug enforcement)
Reported Jul 1, 2020
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 10, 2020
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
Matched: Brand · Product details — Some bottles may contain mixed strengths of the product.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 5, 2020
Teva Pharmaceuticals USA Inc. recalls Actavis Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg due to Due to detection of…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product — Due to detection of N-Nitrosodimethylamine (NDMA)
FDA (recalls & safety alerts)
Reported May 13, 2020
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
FDA (openFDA drug enforcement)
Reported Apr 15, 2020
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Reason for recall — CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 11, 2020
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand — Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
FDA (openFDA drug enforcement)
Reported Feb 26, 2020
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing…
FDA (openFDA drug enforcement)
Reported Feb 19, 2020
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, 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 — CGMP deviations: Product bottle may be absent of desiccant.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2020
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — GMP Deviations: Product bottle may be absent of desiccant.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 27, 2019
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand — Presence of foreign substance: Brown/black particles found during stability testing.
FDA (openFDA drug enforcement)
Reported Oct 16, 2019
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, 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 — GMP Deviation: lot not intended for commercial distribution.
FDA (openFDA drug enforcement)
Reported Jul 17, 2019
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Reason for recall — CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 11, 2019
Teva Pharmaceuticals USA, Inc. recalls GSMS Inc. Losartan potassium tablets due to Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product — Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
FDA (recalls & safety alerts)
Reported Apr 24, 2019
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Subpotent Product: assay results for Amoxicillin were below the specification limits.
FDA (openFDA drug enforcement)
Reported Mar 27, 2019
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each),…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Subpotent Drug.
FDA (openFDA drug enforcement)
Reported Jan 23, 2019
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed dissolution specifications
FDA (openFDA drug enforcement)
Reported Dec 19, 2018
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
7 more products in this recall
FDA (openFDA drug enforcement)
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