Dr. Reddy's' product recalls
26 official recall notices between Nov 2023 and Dec 2025 were matched to Dr. Reddy's.
Each notice concerns the specific products, sizes and lot codes it names. A recall does not mean that other Dr. Reddy's products are affected, and a count of notices is not a measure of safety: one incident can produce a notice for every pack size.
Covers only notices from the U.S. Food and Drug Administration enforcement reports (openFDA), USDA Food Safety and Inspection Service recalls, UK Food Standards Agency food alerts and U.S. Consumer Product Safety Commission recalls that could be matched to Dr. Reddy's: the recalling firm must be Dr. Reddy's, a parent or a subsidiary, and for a brand the brand name must appear in the product description. Method.
2025 (4)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 | — | Dr. Reddy's Laboratories, Inc. | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. Class III | FDA | |
| 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. | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. Class II | FDA | |
| Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA,… | — | Dr. Reddy's Laboratories, Inc. | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole… Class II | FDA | |
| 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… | — | Dr. Reddy's Laboratories, Inc. | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while… Class I | FDA |
2024 (21)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in… | — | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications Class III | FDA | |
| 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 | — | Dr. Reddy's Laboratories, Inc. | Failed Tablet/Capsule Specifications Class III | FDA | |
| Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. | — | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specification Class II | FDA | |
| Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. | — | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specification Class II | FDA | |
| Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. | — | Dr. Reddy's Laboratories, Inc. | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II | FDA | |
| Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. | — | Dr. Reddy's Laboratories, Inc. | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II | FDA | |
| Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. | — | Dr. Reddy's Laboratories, Inc. | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II | FDA | |
| 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… | — | Dr. Reddy's Laboratories, Inc. | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10%… Class II | FDA | |
| 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… | — | Dr. Reddy's Laboratories, Inc. | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10%… Class II | FDA | |
| 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… | — | Dr. Reddy's Laboratories, Inc. | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10%… Class II | FDA | |
| Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,… | — | Dr. Reddy's Laboratories, Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets Class III | FDA | |
| 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 | — | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications: Related Substances Class III | FDA | |
| 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. | — | Dr. Reddy's Laboratories, Inc. | Presence of foreign substance. Class II | FDA | |
| Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made… | — | Dr. Reddy's Laboratories, Inc. | Lack of Assurance of Sterility: Leaking vials Class II | FDA | |
| 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 | — | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications Class III | FDA | |
| Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,… | — | Dr. Reddy's Laboratories, Inc. | Sub-potent Drug; powder discoloration associated with decreased potency Class I | FDA | |
| Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton,… | — | Dr. Reddy's Laboratories, Inc. | Sub-potent Drug; powder discoloration associated with decreased potency Class I | FDA | |
| Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01 | — | Dr. Reddy's Laboratories, Inc. | Misprint on tablet Class III | FDA | |
| Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05 | — | Dr. Reddy's Laboratories, Inc. | Misprint on tablet Class III | FDA | |
| Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01 | — | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. Class II | FDA | |
| Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15 | — | Dr. Reddy's Laboratories, Inc. | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. Class II | FDA |
2023 (1)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC#… | — | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as… Class II | FDA |
Product descriptions and reasons are shortened from the regulators' own text; the linked notice is the authoritative record. See all matched recalls, or report a wrong match through the corrections page.