Recall archive
80 recalls · page 1 of 4
Reported Dec 17, 2025
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in…
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 — Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
FDA (openFDA drug enforcement)
Reported Oct 15, 2025
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured 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 — Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
FDA (openFDA drug enforcement)
Reported Apr 23, 2025
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland…
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 MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum…
FDA (openFDA drug enforcement)
Reported Dec 18, 2024
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: 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
FDA (openFDA drug enforcement)
Reported Nov 27, 2024
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: 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 Tablet/Capsule Specifications
FDA (openFDA drug enforcement)
Reported Nov 13, 2024
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Brand — Failed Impurities/Degradation Specification
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 6, 2024
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,…
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 N-nitroso Cinacalcet impurity above FDA recommended interim limit
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 4, 2024
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in…
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: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 14, 2024
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: 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 — Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
FDA (openFDA drug enforcement)
Reported Jul 10, 2024
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 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 · Product details — Failed Impurities/Degradation Specifications: Related Substances
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 5, 2024
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: 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 — Lack of Assurance of Sterility: Leaking vials
FDA (openFDA drug enforcement)
Reported May 29, 2024
Sirolimus Tablets 1mg Tablets 100-count bottle, 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 Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported May 15, 2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Dr. Reddy's Laboratories, Inc.
Matched: Brand · Product details — Sub-potent Drug; powder discoloration associated with decreased potency
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 14, 2024
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409…
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 — Misprint on tablet
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 17, 2024
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured 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 — Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 15, 2023
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed 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 — Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25…
FDA (openFDA drug enforcement)
Reported Jul 12, 2023
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Amerisource Health Services LLC
Matched: Reason for recall — Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…
FDA (openFDA drug enforcement)
Reported Mar 1, 2023
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500…
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: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg…
FDA (openFDA drug enforcement)
Reported Dec 7, 2022
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release…
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
FDA (openFDA drug enforcement)
Reported Oct 12, 2022
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed 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 — Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
FDA (openFDA drug enforcement)
Reported Aug 3, 2022
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10…
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
1 more product in this recall
FDA (openFDA drug enforcement)
Reported May 11, 2022
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister…
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 Apr 6, 2022
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. 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: Out of Specification results for related substance.
2 more products in this recall
FDA (openFDA drug enforcement)
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