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.

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DateProductReasonClassFirm
Sep 12, 2018 Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd B... Failed Impurities/Degradation Specifications: OOS for unknown impurities. Class III Dr. Reddy's Laboratories, Inc.
Sep 12, 2018 Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bot... Failed Impurities/Degradation Specifications: OOS for unknown impurities. Class III Dr. Reddy's Laboratories, Inc.
Sep 4, 2018 Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Red... Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl T... Class II Dr. Reddy's Laboratories, Inc.
Aug 2, 2018 Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R... Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot... Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
May 30, 2018 Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr.... Presence of Foreign Substance: A product complaint was received for a defective tablet with an em... Class II Dr. Reddy's Laboratories, Inc.
Apr 23, 2018 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottl... Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was foun... Class II Dr. Reddy's Laboratories, Inc.
Mar 8, 2018 Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Oct 30, 2017 Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, me... Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt... Class III Dr. Reddy's Laboratories, Inc.
Oct 3, 2017 Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV... Failed impurities/degradation specifications: Famotodine has an out of specification result for a... Class III Dr. Reddy's Laboratories, Inc.
Jul 11, 2017 Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC ... Failed Impurities/Degradation Specifications: high out of specification results for related impur... Class III Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2017 Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P... Failed Dissolution Specifications: out of specification results observed for low dissolution. Class II Dr. Reddy's Laboratories, Inc.
Mar 6, 2017 RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. B... Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsul... Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Jan 9, 2017 Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr... Defective Container: Product complaints received of defect in the seal of the Docetaxel injection... Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Oct 13, 2016 Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd:... Failed impurities/degradation specifications: due to out-of-specification result for the Related ... Class III Dr. Reddy's Laboratories, Inc.
Sep 8, 2016 Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart... Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but... Class III Mckesson Packaging Services
Aug 29, 2016 ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 3, 2016 Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Redd... Failed impurities/degradation: out of specification result for impurity secorapamycin. Class III Dr. Reddy's Laboratories, Inc.
Apr 22, 2016 CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottl... Failed impurities/degradation specification: An out of specification results has been determined ... Class III Dr. Reddy's Laboratories, Inc.
Mar 30, 2016 Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr... Failed Impurities/Degradation Specifications; 12 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Mar 3, 2016 Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle... Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tigh... Class II Dr. Reddy's Laboratories, Inc.
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.

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.