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 |
|---|---|---|---|---|
| Aug 26, 2019 | minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physici... | Failed Dissolution Specifications: | Class III | EPI Health, LLC |
| Apr 24, 2019 | DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-un... | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Class II | MAJOR PHARMACEUTICALS |
| Apr 11, 2019 | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (... | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 6, 2019 | Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx onl... | Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterilit... | Class II | Dr. Reddy's Laboratories, Inc. |
| Feb 6, 2019 | Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottl... | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 31, 2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx ... | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jan 15, 2019 | Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, M... | Presence of Foreign Substance: Product complaint of black speckles observed on tablets. | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 10, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Nov 7, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 26, 2018 | Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), F... | Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and ... | Class I | Dr. Reddy's Laboratories, Inc. |
| Sep 21, 2018 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, ... | Failed stability specifications - An out of specification result was observed for the test parame... | Class II | Dr. Reddy's Laboratories, Inc. |
| 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. |
| Jan 5, 2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jan 5, 2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| 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. |
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.