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Dr. Reddy's Laboratories Recalls
165 recalls on record · August 8, 2012 to December 17, 2025 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 13, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-12
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
April 24, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (ND
Hazard: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
March 20, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited
Hazard: Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
February 27, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limi
Hazard: Failed Dissolution Specifications: Out of specification results observed for high dissolution.
February 20, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (
Hazard: Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
February 20, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL In
Hazard: Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
January 30, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind.
Hazard: Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
December 19, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laborato
Hazard: Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
November 28, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laborato
Hazard: Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
October 10, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44)
Hazard: Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
October 3, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma
Hazard: Failed Impurities/Degradation Specifications: OOS for unknown impurities.
October 3, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 04
Hazard: Failed Impurities/Degradation Specifications: OOS for unknown impurities.
September 26, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532
Hazard: Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
August 22, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 5
Hazard: Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 5511
Hazard: Failed Impurities/Degradation Specifications
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -
Hazard: Failed Impurities/Degradation Specifications
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -
Hazard: Failed Impurities/Degradation Specifications
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -
Hazard: Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
May 16, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's La
Hazard: Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
March 21, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 0
Hazard: Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
February 7, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA
Hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
February 7, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd
Hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
February 7, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd
Hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
January 17, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatn
Hazard: Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
November 15, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube,
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
October 18, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-3
Hazard: Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
August 9, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
June 14, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By:
Hazard: Failed Dissolution Specifications: out of specification results observed for low dissolution.
June 14, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By:
Hazard: Failed Dissolution Specifications: out of specification results observed for low dissolution.
June 14, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By:
Hazard: Failed Dissolution Specifications: out of specification results observed for low dissolution.