Recall archive
80 recalls · page 3 of 4
Reported Jun 27, 2018
Atorvastatin Calcium Tablets, 80 mg*, 90-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 — Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported May 16, 2018
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, 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 — Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante…
FDA (openFDA drug enforcement)
Reported Mar 21, 2018
Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ…
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:Out-of-specification results observed for viscosity during stability testing.
FDA (openFDA drug enforcement)
Reported Feb 7, 2018
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, 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/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 17, 2018
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited,…
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: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is…
FDA (openFDA drug enforcement)
Reported Nov 15, 2017
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
FDA (openFDA drug enforcement)
Reported Oct 18, 2017
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during…
FDA (openFDA drug enforcement)
Reported Aug 9, 2017
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles…
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: high out of specification results for related impurity for lot C700220.
FDA (openFDA drug enforcement)
Reported Jun 14, 2017
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured…
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: out of specification results observed for low dissolution.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 12, 2017
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, 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 — Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
FDA (openFDA drug enforcement)
Reported Mar 8, 2017
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:…
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 dissolution specifications - low dissolution results at S3 stage.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 15, 2017
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, 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 out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18…
FDA (openFDA drug enforcement)
Reported Feb 8, 2017
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx 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; 18 month stability time point
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 19, 2016
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla 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 details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Jul 13, 2016
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam -…
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: out of specification result for impurity secorapamycin.
FDA (openFDA drug enforcement)
Reported Jul 6, 2016
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability…
FDA (openFDA drug enforcement)
Reported May 18, 2016
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications; 12 month stability time point
FDA (openFDA drug enforcement)
Reported Apr 6, 2016
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
FDA (openFDA drug enforcement)
Reported Feb 24, 2016
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally,…
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 Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 2, 2015
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr.…
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 — Subpotent Drug: Subpotent atorvastatin.
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 19, 2015
Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited,…
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
FDA (openFDA drug enforcement)
Reported Jun 24, 2015
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500…
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; exceeded specification at the 9 hour time point
5 more products in this recall
FDA (openFDA drug enforcement)
Reported May 20, 2015
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cipla Limited
Matched: Product details — Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
FDA (openFDA drug enforcement)
Reported Jun 18, 2014
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr.…
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: Failure of dissolution test observed at the 18 month time point.
FDA (openFDA drug enforcement)
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