Browse Drug Recalls
167 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 167 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 167 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 11, 2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 26, 2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL ... | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative co... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 30, 2025 | Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, M... | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250m... | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 13, 2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... | Class I | Dr. Reddy's Laboratories, Inc. |
| Nov 22, 2024 | Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx On... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 29, 2024 | IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. ... | Failed Tablet/Capsule Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 22, 2024 | Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only,... | Failed Impurities/Degradation Specification | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 22, 2024 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx On... | Failed Impurities/Degradation Specification | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratorie... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 6, 2024 | IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laborat... | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 6, 2024 | IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laborat... | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 6, 2024 | IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laborat... | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 26, 2024 | Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 7, 2024 | Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured... | Presence of foreign substance. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 4, 2024 | Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Redd... | Failed Impurities/Degradation Specifications: Related Substances | Class III | Dr. Reddy's Laboratories, Inc. |
| May 23, 2024 | Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials... | Lack of Assurance of Sterility: Leaking vials | Class II | Dr. Reddy's Laboratories, Inc. |
| May 1, 2024 | Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. ... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Apr 8, 2024 | Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... | Sub-potent Drug; powder discoloration associated with decreased potency | Class I | Dr. Reddy's Laboratories, Inc. |
| Apr 8, 2024 | Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... | Sub-potent Drug; powder discoloration associated with decreased potency | Class I | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 2, 2024 | Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's ... | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 15, 2023 | Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr... | Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tac... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 13, 2023 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distribute... | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast S... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 23, 2023 | Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... | Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... | Class II | Amerisource Health Services LLC |
| Feb 8, 2023 | Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Redd... | Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bot... | Class II | Dr. Reddy's Laboratories, Inc. |
| Nov 21, 2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 14, 2022 | Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ... | Failed Stability Specifications: Out of specification results reported at 12-month stability test... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 15, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 23, 2022 | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... | Failed Dissolution Specifications; during long term stability testing. | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 23, 2022 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... | Failed Dissolution Specifications; during long term stability testing. | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 16, 2022 | Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 17, 2022 | Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... | Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 10, 2022 | Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.