--- title: "Dr. Reddy's Laboratories, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Dr. Reddy's Laboratories, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/dr-reddy-s-laboratories-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Dr. Reddy's Laboratories, Inc. recall records **23** reported ongoing 65 records in this archive. Latest source date Nov 11, 2025. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Nov 11, 2025 FDA drug enforcement ### [Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56](https://isitonrecall.com/recall/fda-drug-d-0219-2026-varenicline-tablets-1mg-56-tablets-rx-only-distributor-dr-reddy-s-laboratories-inc-princeton-nj-0854/) Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. Class III Reported ongoing Distribution: Distributed Nationwide [Official source for Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Prince...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0219-2026%22) Sep 26, 2025 FDA drug enforcement ### [Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laborat...](https://isitonrecall.com/recall/fda-drug-d-0008-2026-succinylcholine-chloride-injection-usp-200-mg-10-ml-20-mg-ml-25-x-10-ml-multiple-dose-vials-for-intr/) Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. Class II Reported ongoing Distribution: Nationwide within the USA. [Official source for Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0008-2026%22) Jun 30, 2025 FDA drug enforcement ### [Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qual...](https://isitonrecall.com/recall/fda-drug-d-0525-2025-omeprazole-delayed-release-capsules-usp-20mg-1000-count-bottle-rx-only-manufactured-by-dr-reddy-s-la/) Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. Class II Reported ongoing Distribution: USA Nationwide [Official source for Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0525-2025%22) Mar 13, 2025 FDA drug enforcement ### [Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: ...](https://isitonrecall.com/recall/fda-drug-d-0365-2025-levetiracetam-0-75-in-sodium-chloride-injection-1-000-mg-100-ml-10-mg-ml-1-x-100ml-rx-only-manufactu/) 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 in 0.75% Sodium Chloride Injection 1,0... Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0365-2025%22) Nov 22, 2024 FDA drug enforcement ### [Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.](https://isitonrecall.com/recall/fda-drug-d-0117-2025-javygtor-sapropterin-dihydrochloride-tablets-100mg-120-count-bottle-rx-only-distributor-dr-reddy-s-l/) Failed Impurities/Degradation Specifications Class III Reported ongoing Distribution: U.S. Nationwide [Official source for Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr....](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0117-2025%22) Oct 29, 2024 FDA drug enforcement ### [IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05](https://isitonrecall.com/recall/fda-drug-d-0047-2025-ibu-ibuprofen-600-mg-tablets-500-count-bottle-rx-only-distributor-dr-reddy-s-laboratories-inc-prince/) Failed Tablet/Capsule Specifications Class III Reported ongoing Distribution: USA Nationwide [Official source for IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0047-2025%22) Oct 22, 2024 FDA drug enforcement ### [Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.](https://isitonrecall.com/recall/fda-drug-d-0036-2025-morphine-sulfate-extended-release-tablets-15-mg-100-count-per-bottle-rx-only-manufactured-by-mayne-p/) Failed Impurities/Degradation Specification Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0036-2025%22) Oct 22, 2024 FDA drug enforcement ### [Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.](https://isitonrecall.com/recall/fda-drug-d-0037-2025-morphine-sulfate-extended-release-tablets-30-mg-100-count-bottles-rx-only-manufactured-by-mayne-phar/) Failed Impurities/Degradation Specification Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayn...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0037-2025%22) Oct 9, 2024 FDA drug enforcement ### [Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.](https://isitonrecall.com/recall/fda-drug-d-0026-2025-cinacalcet-tablets-30-mg-30-count-bottle-rx-only-dr-reddy-s-laboratories-inc-princeton-nj-08540-made/) CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Reported ongoing Distribution: USA Nationwide. [Official source for Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0026-2025%22) Oct 9, 2024 FDA drug enforcement ### [Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.](https://isitonrecall.com/recall/fda-drug-d-0027-2025-cinacalcet-tablets-60-mg-30-count-bottles-rx-only-dr-reddy-s-laboratories-inc-princeton-nj-08540-mad/) CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Reported ongoing Distribution: USA Nationwide. [Official source for Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0027-2025%22) Oct 9, 2024 FDA drug enforcement ### [Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.](https://isitonrecall.com/recall/fda-drug-d-0028-2025-cinacalcet-tablets-90-mg-30-count-bottle-rx-only-dr-reddy-s-laboratories-inc-princeton-nj-08540-made/) CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Reported ongoing Distribution: USA Nationwide. [Official source for Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0028-2025%22) Aug 6, 2024 FDA drug enforcement ### [IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 5...](https://isitonrecall.com/recall/fda-drug-d-0644-2024-ibu-ibuprofen-tablets-usp-800-mg-rx-only-distributor-dr-reddy-s-laboratories-inc-princeton-nj-08540/) Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeto...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0644-2024%22) Aug 6, 2024 FDA drug enforcement ### [IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5...](https://isitonrecall.com/recall/fda-drug-d-0645-2024-ibu-ibuprofen-tablets-usp-600-mg-rx-only-distributor-dr-reddy-s-laboratories-inc-princeton-nj-08540/) Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeto...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0645-2024%22) Aug 6, 2024 FDA drug enforcement ### [IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC...](https://isitonrecall.com/recall/fda-drug-d-0646-2024-ibu-ibuprofen-tablets-usp-400-mg-rx-only-distributor-dr-reddy-s-laboratories-inc-princeton-nj-08540/) Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeto...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0646-2024%22) Jun 26, 2024 FDA drug enforcement ### [Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43...](https://isitonrecall.com/recall/fda-drug-d-0625-2024-sevelamer-carbonate-for-oral-suspension-0-8g-packets-packaged-in-90-packets-per-container-distributo/) Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets Class III Reported ongoing Distribution: Nationwide within the United States [Official source for Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distr...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0625-2024%22) Jun 7, 2024 FDA drug enforcement ### [Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.](https://isitonrecall.com/recall/fda-drug-d-0583-2024-allopurinol-tablets-usp-300mg-100-tablets-per-bottle-rx-only-manufactured-by-dr-reddy-s-laboratories/) Presence of foreign substance. Class II Reported terminated Distribution: IL, MS, OH [Official source for Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Lab...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0583-2024%22) Jun 4, 2024 FDA drug enforcement ### [Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30](https://isitonrecall.com/recall/fda-drug-d-0581-2024-eszopiclone-tablets-usp-1mg-civ-30-count-bottle-rx-only-mfd-by-dr-reddy-s-laboratories-limited-bachu/) Failed Impurities/Degradation Specifications: Related Substances Class III Reported ongoing Distribution: OH, MS [Official source for Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Lim...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0581-2024%22) May 23, 2024 FDA drug enforcement ### [Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111...](https://isitonrecall.com/recall/fda-drug-d-0510-2024-zoledronic-acid-injection-5mg-100ml-sterile-solution-100ml-single-dose-vials-rx-only-distributor-dr/) Lack of Assurance of Sterility: Leaking vials Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distribut...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0510-2024%22) May 1, 2024 FDA drug enforcement ### [Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01](https://isitonrecall.com/recall/fda-drug-d-0504-2024-sirolimus-tablets-1mg-tablets-100-count-bottle-rx-only-distributed-by-dr-reddy-s-laboratories-inc-pr/) Failed Impurities/Degradation Specifications Class III Reported ongoing Distribution: US Nationwide. [Official source for Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0504-2024%22) Apr 23, 2024 FDA company announcement ### [Dr. Reddy’s: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg](https://isitonrecall.com/recall/fdapress-91da8cdf5f10607a-dr-reddy-s-sapropterin-dihydrochloride-powder-for-oral-solution-100-mg/) Decreased Potency Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Dr. Reddy’s: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg) ## Reasons in these listed records - Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. - Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. - Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. - 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 in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. These examples come from this result page and are not a ranking of every recall reason. ## Checking Dr. Reddy's Laboratories, Inc. ### Is there a recall on dr. reddy's laboratories, inc. right now? This archive contains 65 records, including 23 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Dr. Reddy's Laboratories, Inc.](https://isitonrecall.com/check/?q=Dr.%20Reddy%27s%20Laboratories%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)