Records and reported status
May 23, 2025 FDA drug enforcement
Presence of foreign tablets/capsules.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hr... Jan 10, 2025 FDA drug enforcement
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class II Reported ongoing
Distribution: Product was distributed nationwide.
Official source for Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1... Aug 8, 2024 FDA drug enforcement
Superpotent Drug
Class II Reported ongoing
Distribution: Product was distributed nationwide within the United States
Official source for Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, ... Jun 28, 2024 FDA drug enforcement
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class II Reported ongoing
Distribution: Nationwide in the USA and Puerto Rico
Official source for Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Cana... Jun 4, 2024 FDA drug enforcement
Subpotent Drug
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only... Mar 28, 2024 FDA drug enforcement
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured Fo... Mar 7, 2024 FDA drug enforcement
Failed Dissolution Specifications
Class II Reported terminated
Distribution: USA nationwide.
Official source for Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in... Jan 25, 2024 FDA drug enforcement
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III Reported ongoing
Distribution: nationwide
Official source for Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carto... Jan 25, 2024 FDA drug enforcement
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III Reported ongoing
Distribution: nationwide
Official source for Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in c... Jan 8, 2024 FDA drug enforcement
Failed Dissolution Specifications
Class II Reported ongoing
Distribution: Nationwide
Official source for Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Labor... Nov 10, 2023 FDA drug enforcement
OOS for viscosity
Class III Reported terminated
Distribution: USA nationwide
Official source for Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx o... Jul 5, 2023 FDA drug enforcement
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class II Reported terminated
Distribution: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Official source for Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceutic... Apr 27, 2023 FDA drug enforcement
Labeling: Incorrect or Missing Package Insert
Class III Reported terminated
Distribution: US Nationwide
Official source for Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 card... Apr 27, 2023 FDA drug enforcement
Labeling: Incorrect or Missing Package Insert
Class III Reported terminated
Distribution: US Nationwide
Official source for Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 card... Apr 27, 2023 FDA drug enforcement
Labeling: Incorrect or Missing Package Insert
Class III Reported terminated
Distribution: US Nationwide
Official source for Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 card... Apr 27, 2023 FDA drug enforcement
Labeling: Incorrect or Missing Package Insert
Class III Reported terminated
Distribution: US Nationwide
Official source for Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 card... Apr 27, 2023 FDA drug enforcement
Labeling: Incorrect or Missing Package Insert
Class III Reported terminated
Distribution: US Nationwide
Official source for Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 card... Mar 27, 2023 FDA drug enforcement
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class III Reported terminated
Distribution: USA Nationwide
Official source for Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, ... Feb 23, 2023 FDA drug enforcement
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II Reported terminated
Distribution: Nationwide in the U.S.A.
Official source for Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, U... Feb 22, 2023 FDA drug enforcement
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II Reported terminated
Distribution: CA
Official source for Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured...
Reasons in these listed records Presence of foreign tablets/capsules. Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit Superpotent Drug Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. These examples come from this result page and are not a ranking of every recall reason.
Checking Teva Pharmaceuticals USA Inc Is there a recall on teva pharmaceuticals usa inc right now? This archive contains 51 records, including 29 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.