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Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc.: 163 FDA recall reports
Every drug recall the FDA has published for Dr. Reddy's Laboratories, Inc.. The fault, and how the agency graded it.
163Reports
5Class I
23Ongoing
2025-12-17Most recent
5 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540
D-0219-2026 · Class III · reported 2025-12-17 · Ongoing
- Why it was recalled
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Where it went
- Distributed Nationwide
- How much
- 4800 54-count bottles
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intraven
D-0008-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
- Product
- 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: 43598-666-25
- Where it went
- Nationwide within the USA.
- How much
- 571 vials
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Labor
D-0525-2025 · Class II · reported 2025-07-23 · Ongoing
- Why it was recalled
- Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- Product
- Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
- Where it went
- USA Nationwide
- How much
- 1476 bottles
Class I
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured
D-0365-2025 · Class I · reported 2025-04-23 · Ongoing
- Why it was recalled
- 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.
- Product
- 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, NJ 08540, NDC 43598-636-52
- Where it went
- Nationwide in the USA
- How much
- 4,010 bags
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Labo
D-0117-2025 · Class III · reported 2024-12-18 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- 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.
- Where it went
- U.S. Nationwide
- How much
- 7,233 bottles
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Prince
D-0047-2025 · Class III · reported 2024-11-27 · Ongoing
- Why it was recalled
- Failed Tablet/Capsule Specifications
- Product
- 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
- Where it went
- USA Nationwide
- How much
- 3416 botttles
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma,
D-0036-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specification
- Product
- Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
- Where it went
- Nationwide in the USA
- How much
- 2,040 100-count bottles
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Gr
D-0037-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specification
- Product
- Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
- Where it went
- Nationwide in the USA
- How much
- 532 100-count bottles
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made i
D-0028-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Product
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
- Where it went
- USA Nationwide.
- How much
- 10584 bottles
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made
D-0027-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Product
- Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
- Where it went
- USA Nationwide.
- How much
- 35880 bottles
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made i
D-0026-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Product
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
- Where it went
- USA Nationwide.
- How much
- 285126 bottles
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,
D-0644-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Product
- 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 55111-684-05 - 500 Tablets per bottle.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 103,298 bottles
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,
D-0646-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Product
- 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 55111-682-05 - 500 Tablets per bottle.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 14940 bottles
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,
D-0645-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Product
- 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 5511-683-05 - 500 Tablets per bottle.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 31,802 bottles
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. R
D-0625-2024 · Class III · reported 2024-08-14 · Ongoing
- Why it was recalled
- Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- Product
- 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
- Where it went
- Nationwide within the United States
- How much
- 5,136 cartons
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA
D-0583-2024 · Class II · reported 2024-07-10 · Terminated
- Why it was recalled
- Presence of foreign substance.
- Product
- 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.
- Where it went
- IL, MS, OH
- How much
- 20,520 units
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupa
D-0581-2024 · Class III · reported 2024-07-10 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Related Substances
- Product
- 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
- Where it went
- OH, MS
- How much
- 13,752 bottles
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy
D-0510-2024 · Class II · reported 2024-06-05 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: Leaking vials
- Product
- 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 55111-688-52
- Where it went
- Nationwide within the United States
- How much
- 13,880 vials
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Prince
D-0504-2024 · Class III · reported 2024-05-29 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- 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
- Where it went
- US Nationwide.
- How much
- 1,176 bottles
Class I
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distrib
D-0486-2024 · Class I · reported 2024-05-15 · Ongoing
- Why it was recalled
- Sub-potent Drug; powder discoloration associated with decreased potency
- Product
- 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 43598-477-30.
- Where it went
- Nationwide in the USA
- How much
- 2402 cartons
Class I
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx On
D-0485-2024 · Class I · reported 2024-05-15 · Ongoing
- Why it was recalled
- Sub-potent Drug; powder discoloration associated with decreased potency
- Product
- 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.
- Where it went
- Nationwide in the USA
- How much
- 17,332 cartons
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakula
D-0313-2024 · Class III · reported 2024-02-14 · Ongoing
- Why it was recalled
- Misprint on tablet
- Product
- Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
- Where it went
- Nationwide
- How much
- 14,425 bottles
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakula
D-0312-2024 · Class III · reported 2024-02-14 · Ongoing
- Why it was recalled
- Misprint on tablet
- Product
- Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
- Where it went
- Nationwide
- How much
- 59,336 bottles
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, B
D-0219-2024 · Class II · reported 2024-01-17 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- Product
- Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
- Where it went
- US Nationwide.
- How much
- 8,280 bottles
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam
D-0223-2024 · Class II · reported 2024-01-17 · Completed
- Why it was recalled
- Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
- Product
- Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
- Where it went
- USA Nationwide
- How much
- 38,952 bottles
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories.,
D-0086-2024 · Class II · reported 2023-11-15 · Terminated
- Why it was recalled
- 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 mg.
- Product
- Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
- Where it went
- Nationwide
- How much
- 1,656 bottles
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupa
D-0330-2023 · Class II · reported 2023-03-01 · Ongoing
- Why it was recalled
- 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 capsules.
- Product
- Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
- Where it went
- Nationwide in the USA
- How much
- 4,320 bottles
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-
D-0073-2023 · Class III · reported 2022-12-07 · Terminated
- Why it was recalled
- Failed dissolution specifications
- Product
- Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India
- Where it went
- Nationwide in the USA
- How much
- 25,176, 30-count; 22,968 20-count
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed
D-0007-2023 · Class III · reported 2022-10-12 · Completed
- Why it was recalled
- Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- Product
- 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
- Where it went
- USA nationwide
- How much
- 2,838 ampules
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of
D-1287-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- FAILED DISSOLUTION SPECIFICATIONS
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
- Where it went
- Nationwide in the USA
- How much
- 2,892 cartons
Showing the 30 most recent of 163. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All drug recalls