Dr. Reddy's Laboratories, Inc. recalls
17 recalls on record · 3 rated Critical · FDA
Every recall we have on record for Dr. Reddy's Laboratories, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories…
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured…
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL,…
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's…
Failed Tablet/Capsule Specifications
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr.…
Presence of foreign substance.
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's…
Failed Impurities/Degradation Specifications
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per…
Sub-potent Drug; powder discoloration associated with decreased potency
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual…
Sub-potent Drug; powder discoloration associated with decreased potency
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's…
Misprint on tablet
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's…
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal…
Failed dissolution specifications
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per…
FAILED DISSOLUTION SPECIFICATIONS
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per…
FAILED DISSOLUTION SPECIFICATIONS
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's…
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release…
Failed Dissolution Specifications
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl…
Failed Dissolution Specifications