Recall archive
162 recalls · page 1 of 7
Reported Sep 9, 2026Updated Sep 14, 2026
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Presence of Foreign Tablets/Capsules
FDA (openFDA drug enforcement)
Reported May 13, 2026
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
FDA (openFDA drug enforcement)
Reported Apr 29, 2026
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
FDA (openFDA drug enforcement)
Reported Apr 15, 2026
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, 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 — Superpotent and Subpotent
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 1, 2026
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 11, 2026
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Dissolution Specifications
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand — Defective Container - A defect in the side-seal which allows leakage of product.
FDA (openFDA drug enforcement)
Reported Nov 12, 2025
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Subpotent drug; Clavulanate Potassium component
FDA (openFDA drug enforcement)
Reported Nov 5, 2025
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 2, 2025
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Presence of foreign tablets/capsules.
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
FDA (openFDA drug enforcement)
Reported Aug 28, 2024
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Superpotent Drug
FDA (openFDA drug enforcement)
Reported Aug 14, 2024
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Novel Laboratories, Inc. d.b.a Lupin Somerset
Matched: Product details — Defective container: potential for non-sealed pouches which can lead to product leakage.
FDA (openFDA drug enforcement)
Reported Jul 24, 2024
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the…
FDA (openFDA drug enforcement)
Reported Jun 26, 2024
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Subpotent Drug
FDA (openFDA drug enforcement)
Reported Apr 17, 2024
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
FDA (openFDA drug enforcement)
Reported Apr 3, 2024
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Feb 21, 2024
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 7, 2024
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Dec 6, 2023
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, 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 — OOS for viscosity
FDA (openFDA drug enforcement)
Reported Jul 19, 2023
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product · Product details — Failed Moisture Limits: Water (moisture) content above the approved product specifications.
FDA (openFDA drug enforcement)
Reported May 31, 2023
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA Inc.
Matched: Brand — Labeling: Incorrect or Missing Package Insert
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 12, 2023
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed 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 Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
FDA (openFDA drug enforcement)
Reported Mar 22, 2023
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand — Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
FDA (openFDA drug enforcement)
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