Browse Drug Recalls
182 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 182 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 182 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 4, 2015 | Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 4, 2015 | Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... | Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count ... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count ... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged i... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count B... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 13, 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count B... | Subpotent Drug: Subpotent atorvastatin. | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 3, 2015 | Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2015 | Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 25... | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2015 | Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, R... | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Class II | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bot... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in ... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| May 6, 2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| Apr 24, 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Cipla Limited |
| May 23, 2014 | Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-cou... | Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 9, 2014 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... | Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... | Class II | Legacy Pharmaceutical Packaging |
| Jan 3, 2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... | Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 13, 2013 | Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tabl... | Failed Dissolution Specification; 12-Month stability interval. | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 29, 2013 | IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05)... | Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an inco... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 2, 2013 | Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum S... | Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of... | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 19, 2013 | Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By:... | Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of ... | Class III | Dr. Reddy'S Laboratories |
| Feb 15, 2013 | Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) ... | Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin ... | Class II | Dr Reddys Laboratories Tennessee LLC |
| Sep 27, 2012 | Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... | Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2012 | Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. R... | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2012 | Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. ... | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2012 | Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. R... | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 9, 2012 | Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By... | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 9, 2012 | Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 50... | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... | Class II | 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.