Browse Drug Recalls
1,020 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,020 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 1,020 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 19, 2018 | children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 19, 2018 | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 5, 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... | Class III | Amerigen Pharmaceuticals Inc. |
| Oct 5, 2018 | Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured... | Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuri... | Class II | LUPIN SOMERSET |
| Oct 3, 2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... | Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... | Class III | InvaGen Pharmaceuticals, Inc. |
| Sep 27, 2018 | Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class II | Teva Pharmaceuticals USA |
| Sep 21, 2018 | Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... | Class II | Teva Pharmaceuticals USA |
| 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 20, 2018 | Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... | Failed Stability Specifications: Out-of-specification test result for water content obtained duri... | Class II | Teva Pharmaceuticals USA |
| Sep 11, 2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... | Class II | Torrent Pharma Inc. |
| Aug 28, 2018 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... | Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... | Class III | Pfizer Inc. |
| Aug 27, 2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... | Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 23, 2018 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... | Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being... | Class III | LUPIN SOMERSET |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 3, 2018 | dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distr... | Failed Stability Specifications: separation of product and failure for actives. | Class II | Product Quest Manufacturing LLC |
| 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. |
| Aug 1, 2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... | Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... | Class II | Akorn, Inc. |
| Jul 26, 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Failed Stability Specifications: lot out of specification for elevated water vapor. | Class III | Renaissance Lakewood, LLC |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... | Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... | Class III | Renaissance Lakewood, LLC |
| Jun 29, 2018 | Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... | Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... | Class II | SCA Pharmaceuticals |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 22, 2018 | eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hy... | Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity | Class II | Eb5 Corporation |
| Jun 15, 2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 15, 2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 7, 2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... | Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... | Class III | Mylan Pharmaceuticals Inc. |
| May 7, 2018 | Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perr... | Failed Stability Specifications | Class II | Perrigo New York |
| Apr 30, 2018 | Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... | Failed Stability Specifications | Class III | Teva Pharmaceuticals USA |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 13, 2018 | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ... | Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS... | Class III | Septodont Inc. |
| Apr 10, 2018 | Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co... | Failed Stability Specifications | Class II | Pharmalucence, Inc. |
| Mar 21, 2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... | Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability... | Class III | Mayne Pharma Inc |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 8, 2018 | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... | Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... | Class II | Bracco Diagnostics 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. |
| Mar 7, 2018 | Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (... | Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... | Class II | American Pharmaceutical Ingredients LLC |
| Mar 7, 2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... | Class II | Apollo Care |
| Mar 7, 2018 | Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC... | Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... | Class II | American Pharmaceutical Ingredients LLC |
| Mar 7, 2018 | Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APO... | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... | Class II | Apollo Care |
| Mar 2, 2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... | Superpotent and Failed Stability Specifications; out of specification results for assay and water... | Class III | Renaissance Lakewood, LLC |
| Feb 26, 2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... | Failed Stability Specifications | Class II | Mckesson Packaging Services |
| Feb 21, 2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... | Failed Stability Specification: OOS low viscosity results discovered during retain testing. | Class III | Akorn, Inc. |
| Feb 19, 2018 | Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufact... | cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | Kalchem International, Inc. |
| Feb 15, 2018 | Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOL... | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... | Class II | Apollo Care |
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.