Dr. Reddy's Laboratories recalls
35 official recalls and safety alerts involving Dr. Reddy's Laboratories since 2021-10, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Dr. Reddy's Laboratories or the relevant agency.
- 2025-12-17
USDr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- 2025-10-15
- US
Dr. Reddy's Laboratories, Inc. recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or…
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
- 2025-07-23
- US
Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited,…
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- 2025-04-23
- US
Dr. Reddy's Laboratories, Inc. recalls Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma…
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…
- 2024-12-18
- US
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…
Failed Impurities/Degradation Specifications
- 2024-11-27
- US
- 2024-11-13
- US
Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC…
Failed Impurities/Degradation Specification
- 2024-11-06
- US
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC…
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-09-04
- US
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC…
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- 2024-08-14
- US
Dr. Reddy's Laboratories, Inc. recalls Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories…
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- 2024-07-10
- US
- US
Dr. Reddy's Laboratories, Inc. recalls Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090…
Failed Impurities/Degradation Specifications: Related Substances
- 2024-06-05
- US
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories…
Lack of Assurance of Sterility: Leaking vials
- 2024-05-29
- US
Dr. Reddy's Laboratories, Inc. recalls Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made…
Failed Impurities/Degradation Specifications
- 2024-05-15
- US
Dr. Reddy's Laboratories, Inc. recalls Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's…
Sub-potent Drug; powder discoloration associated with decreased potency
- 2024-02-14
- US
- 2024-01-17
- US
Dr. Reddy's Laboratories, Inc. recalls Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC…
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
- US
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090,…
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- 2023-11-15
- US
Dr. Reddy's Laboratories, Inc. recalls Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ…
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.
- 2023-07-26
- US
Dr Reddy's Laboratories Limited recalls Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409…
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
- 2023-03-01
- US
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090,…
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.
- 2022-12-07
- US
- 2022-10-12
- US
Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's…
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- 2022-08-03
- US
- 2022-05-11
- US
- 2022-04-06
- US
Dr. Reddy's Laboratories, Inc. recalls Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited,…
Failed Dissolution Specifications; during long term stability testing.
- US
Dr. Reddy's Laboratories, Inc. recalls Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409,…
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
- 2022-03-02
- US
Dr. Reddy's Laboratories, Inc. recalls Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's,…
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
- US
- 2022-01-26
- US
- US
- 2021-12-15
- US
- 2021-11-10
- US
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories…
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…
- US
Dr. Reddy's Laboratories, Inc. recalls 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)…
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- 2021-10-27
- US
Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle…
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.