| Nov 11, 2025 |
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... |
Sub potent drug: during the 9-month stability test conducted, the assay value... |
Class III |
| Sep 26, 2025 |
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL ... |
Out-of-Specification (OOS) result during the 6-month stability testing; decre... |
Class II |
| Jun 30, 2025 |
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, M... |
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium E... |
Class II |
| Mar 13, 2025 |
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... |
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetirace... |
Class I |
| Nov 22, 2024 |
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx On... |
Failed Impurities/Degradation Specifications |
Class III |
| Oct 29, 2024 |
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. ... |
Failed Tablet/Capsule Specifications |
Class III |
| Oct 22, 2024 |
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only,... |
Failed Impurities/Degradation Specification |
Class II |
| Oct 22, 2024 |
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx On... |
Failed Impurities/Degradation Specification |
Class II |
| Oct 9, 2024 |
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... |
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommen... |
Class II |
| Oct 9, 2024 |
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratorie... |
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommen... |
Class II |
| Oct 9, 2024 |
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... |
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommen... |
Class II |
| Aug 6, 2024 |
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laborat... |
Failed impurities/degradation specifications: results for unknown impurity, w... |
Class II |
| Aug 6, 2024 |
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laborat... |
Failed impurities/degradation specifications: results for unknown impurity, w... |
Class II |
| Aug 6, 2024 |
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laborat... |
Failed impurities/degradation specifications: results for unknown impurity, w... |
Class II |
| Jun 26, 2024 |
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... |
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and ex... |
Class III |
| Jun 7, 2024 |
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured... |
Presence of foreign substance. |
Class II |
| Jun 4, 2024 |
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Redd... |
Failed Impurities/Degradation Specifications: Related Substances |
Class III |
| May 23, 2024 |
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials... |
Lack of Assurance of Sterility: Leaking vials |
Class II |
| May 1, 2024 |
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. ... |
Failed Impurities/Degradation Specifications |
Class III |
| Apr 8, 2024 |
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... |
Sub-potent Drug; powder discoloration associated with decreased potency |
Class I |
| Apr 8, 2024 |
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... |
Sub-potent Drug; powder discoloration associated with decreased potency |
Class I |
| Jan 18, 2024 |
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... |
Misprint on tablet |
Class III |
| Jan 18, 2024 |
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... |
Misprint on tablet |
Class III |
| Jan 2, 2024 |
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's ... |
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. |
Class II |
| Dec 15, 2023 |
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr... |
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in ... |
Class II |
| Oct 13, 2023 |
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distribute... |
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bot... |
Class II |
| Feb 8, 2023 |
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Redd... |
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule... |
Class II |
| Nov 21, 2022 |
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... |
Failed dissolution specifications |
Class III |
| Sep 14, 2022 |
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ... |
Failed Stability Specifications: Out of specification results reported at 12-... |
Class III |
| Jul 13, 2022 |
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... |
FAILED DISSOLUTION SPECIFICATIONS |
Class II |
| Jul 13, 2022 |
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... |
FAILED DISSOLUTION SPECIFICATIONS |
Class II |
| Apr 15, 2022 |
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... |
Failed Dissolution Specifications |
Class II |
| Mar 23, 2022 |
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... |
Failed Dissolution Specifications; during long term stability testing. |
Class II |
| Mar 23, 2022 |
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... |
Failed Dissolution Specifications; during long term stability testing. |
Class II |
| Mar 16, 2022 |
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... |
Failed Impurities/Degradation Specifications: Out of Specification results fo... |
Class III |
| Feb 17, 2022 |
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... |
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin... |
Class III |
| Jan 19, 2022 |
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... |
Failed stability specifications |
Class III |
| Jan 19, 2022 |
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... |
Failed stability specifications |
Class III |
| Jan 19, 2022 |
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... |
Failed stability specifications |
Class III |
| Jan 10, 2022 |
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... |
Subpotent drug |
Class III |
| Jan 4, 2022 |
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... |
Failed Dissolution Specifications |
Class III |
| Jan 4, 2022 |
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... |
Failed Dissolution Specifications |
Class III |
| Nov 12, 2021 |
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... |
Failed dissolution specifications |
Class III |