Recall archive
80 recalls · page 2 of 4
Reported Mar 2, 2022
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed stability specifications
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 26, 2022
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Failed Dissolution Specifications
9 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 15, 2021
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Failed dissolution specifications
8 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 10, 2021
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 27, 2021
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand — CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
FDA (openFDA drug enforcement)
Reported Aug 25, 2021
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Tablet/Capsule Specification: Some tablets are shaved
FDA (openFDA drug enforcement)
Reported Jun 23, 2021
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
FDA (openFDA drug enforcement)
Reported Jun 2, 2021
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
FDA (openFDA drug enforcement)
Reported Mar 10, 2021
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 3, 2021
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported May 6, 2020
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Discoloration: product contains brown pellets
FDA (openFDA drug enforcement)
Reported Apr 8, 2020
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Defective Container: Recall is due to breaking and shattering of ampules upon opening
FDA (openFDA drug enforcement)
Reported Nov 13, 2019
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Presence of NDMA impurity detected in product.
17 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 24, 2019
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
FDA (openFDA drug enforcement)
Reported Mar 20, 2019
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
FDA (openFDA drug enforcement)
Reported Feb 27, 2019
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications: Out of specification results observed for high dissolution.
FDA (openFDA drug enforcement)
Reported Feb 20, 2019
Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 30, 2019
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
FDA (openFDA drug enforcement)
Reported Dec 19, 2018
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month…
FDA (openFDA drug enforcement)
Reported Nov 28, 2018
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
FDA (openFDA drug enforcement)
Reported Oct 10, 2018
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability…
FDA (openFDA drug enforcement)
Reported Oct 3, 2018
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: OOS for unknown impurities.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 26, 2018
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
FDA (openFDA drug enforcement)
Reported Aug 22, 2018
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam -…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month…
FDA (openFDA drug enforcement)
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