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Drug company (FDA labeler)

Dr. Reddy's Labortories Inc

NDC labeler code: 43598

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
1Products (NDC)
1FDA applications
39Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
March 12, 2025ANDA218773 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		DR Reddys

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2025

  1. November 11, 2025 · Class III · Ongoing · D-0219-2026 · Varenicline tartrate

    Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

    Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

  2. September 26, 2025 · Class II · Ongoing · D-0008-2026 · Succinylcholine

    Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

    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 Laboratories Inc., Princeton, NJ 08540. NDC: 43598

  3. March 13, 2025 · Class I · Ongoing · D-0365-2025 · Levetiracetam

    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.

    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: Dr. Reddy's Laboratories Inc., Princeton, N

  4. January 16, 2025 · Class III · Completed · D-0208-2025 · Venlafaxine hydrochloride

    Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

    Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

2024

  1. November 22, 2024 · Class III · Ongoing · D-0117-2025 · Sapropterin dihydrochloride

    Failed Impurities/Degradation Specifications

    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.

  2. October 9, 2024 · Class II · Ongoing · D-0028-2025 · Cinacalcet

    CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

  3. October 9, 2024 · Class II · Ongoing · D-0027-2025 · Cinacalcet

    CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

  4. October 9, 2024 · Class II · Ongoing · D-0026-2025 · Cinacalcet

    CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

  5. June 26, 2024 · Class III · Ongoing · D-0625-2024 · Sevelamer carbonate

    Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

    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 43598-478-90

  6. April 8, 2024 · Class I · Ongoing · D-0485-2024 · Sapropterin dihydrochloride

    Sub-potent Drug; powder discoloration associated with decreased potency

    Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

Show the 29 older recalls

2022

  1. September 14, 2022 · Class III · Completed · D-0007-2023 · Phytonadione

    Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

    Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

  2. January 26, 2022 · Class II · Terminated · D-0172-2024 · Chlorthalidone

    CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10

  3. January 19, 2022 · Class III · Terminated · D-0576-2022 · Azacitidine

    Failed stability specifications

    Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

  4. January 19, 2022 · Class III · Terminated · D-0575-2022 · Azacitidine

    Failed stability specifications

    Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

2021

  1. October 5, 2021 · Class II · Terminated · D-0081-2022 · Ezetimibe and simvastatin

    Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

    Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, US

  2. October 5, 2021 · Class II · Terminated · D-0082-2022 · Ezetimibe and simvastatin

    Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

    Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Di

  3. October 5, 2021 · Class II · Terminated · D-0084-2022 · Ezetimibe and simvastatin

    Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

    Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Di

  4. October 5, 2021 · Class II · Terminated · D-0085-2022 · Ezetimibe and simvastatin

    Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle

    Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeto

  5. October 5, 2021 · Class II · Terminated · D-0083-2022 · Ezetimibe and simvastatin

    Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

    Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories

  6. March 15, 2021 · Class II · Terminated · D-0469-2021 · Pregabalin

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES

  7. February 26, 2021 · Class II · Terminated · D-0292-2021 · Progesterone

    Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.

    Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.

2020

  1. April 24, 2020 · Class III · Terminated · D-1256-2020 · Esomeprazole

    Discoloration: product contains brown pellets

    Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

  2. March 16, 2020 · Class I · Terminated · D-1094-2020 · Phytonadione

    Defective Container: Recall is due to breaking and shattering of ampules upon opening

    Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 0

2019

  1. March 6, 2019 · Class II · Terminated · D-1001-2019 · Docetaxel

    Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.

    Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.

  2. February 6, 2019 · Class III · Terminated · D-0995-2019 · Esomeprazole

    Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

    Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.

2018

  1. October 26, 2018 · Class I · Terminated · D-0485-2019 · Levetiracetam

    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,

    Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy'

  2. September 12, 2018 · Class III · Terminated · D-0104-2019 · Zoledronic acid

    Failed Impurities/Degradation Specifications: OOS for unknown impurities.

    Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090

2017

  1. January 9, 2017 · Class II · Terminated · D-0213-2018 · Docetaxel

    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.

    Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11

2015

  1. August 13, 2015 · Class III · Terminated · D-1376-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited

  2. August 13, 2015 · Class III · Terminated · D-1374-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.

  3. August 13, 2015 · Class III · Terminated · D-1375-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.

  4. August 13, 2015 · Class III · Terminated · D-1379-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.

  5. August 13, 2015 · Class III · Terminated · D-1377-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limite

  6. August 13, 2015 · Class III · Terminated · D-1378-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited

  7. August 13, 2015 · Class III · Terminated · D-1373-2015 · Amlodipine and atorvastatin

    Subpotent Drug: Subpotent atorvastatin.

    Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.

  8. May 6, 2015 · Class III · Terminated · D-1145-2015 · Amlodipine and atorvastatin

    Subpotent drug

    Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90

  9. May 6, 2015 · Class III · Terminated · D-1144-2015 · Amlodipine and atorvastatin

    Subpotent drug

    Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupal

  10. May 6, 2015 · Class III · Terminated · D-1146-2015 · Amlodipine and atorvastatin

    Subpotent drug

    Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally

  11. May 6, 2015 · Class III · Terminated · D-1143-2015 · Amlodipine and atorvastatin

    Subpotent drug

    Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupall

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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