| Apr 24, 2026 |
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... |
Lack of Assurance of Sterility: Quality system deficiencies identified during... |
Class II |
| Apr 6, 2026 |
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton,... |
Failed Impurities/Degradation Specifications: Out of specification for specif... |
Class II |
| Mar 19, 2026 |
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Syste... |
CGMP Deviations: use of an unapproved raw material |
Class II |
| Mar 19, 2026 |
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Syste... |
CGMP Deviations: use of an unapproved raw material |
Class II |
| Mar 19, 2026 |
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... |
CGMP Deviations: use of an unapproved raw material |
Class II |
| Mar 17, 2026 |
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... |
Lack of Assurance of Sterility: Quality system deficiencies identified during... |
Class II |
| Mar 17, 2026 |
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... |
Lack of Assurance of Sterility: Quality system deficiencies identified during... |
Class II |
| Mar 17, 2026 |
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... |
Lack of Assurance of Sterility: Quality system deficiencies identified during... |
Class II |
| Jan 29, 2026 |
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets b... |
Failed Dissolution Specifications |
Class II |
| Jan 29, 2026 |
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, R... |
Failed Dissolution Specifications |
Class II |
| Jan 29, 2026 |
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (ND... |
Failed Dissolution Specifications |
Class II |
| Jan 29, 2026 |
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (ND... |
Failed Dissolution Specifications |
Class II |
| Jan 12, 2026 |
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manuf... |
Superpotent and Subpotent |
Class II |
| Jan 12, 2026 |
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manuf... |
Superpotent and Subpotent |
Class II |
| Nov 7, 2025 |
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... |
Defective Container - A defect in the side-seal which allows leakage of product. |
Class III |
| Oct 13, 2025 |
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg... |
Subpotent drug; Clavulanate Potassium component |
Class II |
| Oct 7, 2025 |
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... |
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above... |
Class II |
| Oct 7, 2025 |
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... |
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above... |
Class II |
| Oct 7, 2025 |
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... |
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above... |
Class II |
| May 23, 2025 |
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in... |
Presence of foreign tablets/capsules. |
Class II |
| Jan 10, 2025 |
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... |
Failed Stability Specifications - 12-month stability test result for one of t... |
Class II |
| Aug 8, 2024 |
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Te... |
Superpotent Drug |
Class II |
| Jun 28, 2024 |
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, ... |
Failed Impurities/Degradation Specifications: Product is being recalled due t... |
Class II |
| Jun 4, 2024 |
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-co... |
Subpotent Drug |
Class II |
| Mar 28, 2024 |
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... |
Superpotent Drug: The 3-month stability result for assay was found to be abov... |
Class II |
| Mar 7, 2024 |
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... |
Failed Dissolution Specifications |
Class II |
| Jan 25, 2024 |
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... |
Discoloration: discolored tablets (shades of blue) mixed in with the white in... |
Class III |
| Jan 25, 2024 |
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... |
Discoloration: discolored tablets (shades of blue) mixed in with the white in... |
Class III |
| Jan 8, 2024 |
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... |
Failed Dissolution Specifications |
Class II |
| Nov 10, 2023 |
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose pack... |
OOS for viscosity |
Class III |