Dr Reddy's Laboratories recalls
FDA enforcement reports naming Dr Reddy's Laboratories Limited as the recalling firm.
- Recall reports
- 165
- Class I (serious)
- 5
- Most recent report
- Dec 17, 2025
- Dec 17, 2025Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: DrDrug · Dr. Reddy's Laboratories, Inc.Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.Class III
- Oct 15, 2025Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-D…Drug · Dr. Reddy's Laboratories, Inc.Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.Class II
- Jul 23, 2025Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufacture…Drug · Dr. Reddy's Laboratories, Inc.Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.Class II
- Apr 23, 2025Levetiracetam 0Drug · Dr. Reddy's Laboratories, Inc.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…Class I
- Dec 18, 2024Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distri…Drug · Dr. Reddy's Laboratories, Inc.Failed Impurities/Degradation SpecificationsClass III
- Nov 27, 2024IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: DrDrug · Dr. Reddy's Laboratories, Inc.Failed Tablet/Capsule SpecificationsClass III
- Nov 13, 2024Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactu…Drug · Dr. Reddy's Laboratories, Inc.Failed Impurities/Degradation SpecificationClass II
- Nov 13, 2024Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufa…Drug · Dr. Reddy's Laboratories, Inc.Failed Impurities/Degradation SpecificationClass II
- Nov 6, 2024Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, DrDrug · Dr. Reddy's Laboratories, Inc.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitClass II
- Nov 6, 2024Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, DrDrug · Dr. Reddy's Laboratories, Inc.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitClass II
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr
- IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr
- IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr
- IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr
- Sevelamer Carbonate for Oral Suspension 0
- Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr
- Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd
- Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only,…
- Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr
- Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per c…
- Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual pa…
- Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd
- Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd
- Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr
- Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd
- Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr
- Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr
- Tacrolimus Capsules, USP, 0
- Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal…
- Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters p…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters p…
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Table…
- Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd
- Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactur…
- Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-3…
- Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per…
- Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd
- Bortezomib, 3
- Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd
- Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablet…
- Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 12…
- Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg…
- Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine…
- Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decong…
- Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36…
- Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 12…
- CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl…
- QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Releas…
- equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120m…
- Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120…
- Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine H…
- Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Relea…
- Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Al…
- Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Releas…
- Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Releas…
- 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg…
- Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120…
- Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-…
- Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-…
- Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20
- Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr
- Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr
- Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr
- Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles
- Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE
- Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90)
- Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx on…
- Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged…
- Ranitidine Tablets, USP 150 mg, a
- Ranitidine Tablets, USP 75 mg, a
- Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
- Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)
- Ranitidine Tablets, USP 150 mg, 40 count bottles
- Ranitidine Tablets, USP 75 mg
- Ranitidine Tablets, USP 150 mg, a
- Ranitidine Tablets, USP 150 mg, a
- Ranitidine Tablets 75 mg, a
- Ranitidine Tablets, USP 75 mg, a
- Ranitidine Tablets, USP 150 mg, a
- Ranitidine Tablets, USP 150 mg, a
- Ranitidine Tablets, USP 150 mg, a
- Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC
- Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.…
- Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
- Ranitidine Tablets, USP 150 mg
- Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.…
- Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-…
- Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr
- Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd
- Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 435…
- Levetiracetam in 0
- Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufacture…
- Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Man…
- Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Man…
- Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged i…
- Zoledronic Acid Injection, 5 mg/100 mL (0
- Zoledronic Acid Injection, 5mg/100 mL (0
- Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd
- Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr
- Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd
- Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd
- Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90…
- Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd
- Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only…
- Clocortolone Pivalate Cream, 0
- Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd…
- Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd…
- Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr
- Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd
- Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%)
- Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy…
- Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-…
- Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per…
- Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per…
- Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per…
- Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per…
- RIVASTIGMINE Tartrate Capsules, USP, 1
- Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister…
- Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister…
- Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister…
- Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister…
- Olanzapine tablets, USP, 2
- Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC…
- Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC…
- Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd
- Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 5…
- ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only,…
- Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr
- CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, D…
- Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr
- Zoledronic Acid Injection, 5 mg/100 mL (0
- Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr
- Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr
- Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr
- Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Cou…
- Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx…
- Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Co…
- Amlodipine besylate and Atorvastatin calcium Tablets, 2
- Amlodipine besylate and Atorvastatin calcium Tablets, 2
- Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Cou…
- Amlodipine besylate and Atorvastatin calcium Tablets,2
- Rivastigmine Tartrate Capsules, USP 1
- Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count b…
- Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100…
- Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd
- Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count…
- Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count…
- Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx On…
- Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle,…
- a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules…
- Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Onl…
- IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only,…
- Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Ac…
- Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd
- Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr
- Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr
- Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr
- Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Red…
- Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Redd…
- Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules…
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