Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2016 | Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 15, 2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto... | Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod... | Class III | Mckesson Packaging Services |
| Sep 15, 2016 | PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx o... | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expi... | Class III | Pfizer Inc. |
| Sep 13, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-D... | Failed Dissolution Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Sep 13, 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... | Failed Impurities/Degradation Specifications: potential failure to meet the specification for Imp... | Class III | Teva Pharmaceuticals USA |
| Sep 9, 2016 | Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For... | Failed Impurities/Degradations Specifications; Out of specification results for two known degrada... | Class III | Pfizer 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 |
| Sep 7, 2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Vari... | Defective Delivery System: Incorrect type of syringe found in commercially distributed administra... | Class III | Biocompatibles U.K., Ltd. |
| Sep 2, 2016 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx On... | Presence of Foreign Tablets/Capsules | Class III | Shire |
| Sep 1, 2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... | Labeling: Incorrect or Missing Package Insert | Class III | Sanofi-Aventis U.S. LLC |
| Aug 30, 2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... | Class III | Actavis Laboratories, FL, Inc. |
| Aug 29, 2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 23, 2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: ... | Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out... | Class III | Stason Pharmaceuticals, Inc. |
| Aug 19, 2016 | Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Man... | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. | Class III | Unichem Pharmaceuticals Usa Inc |
| Aug 18, 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re... | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of... | Class III | West-Ward Pharmaceuticals Corp. |
| Aug 5, 2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 ... | Failed Impurities/Degradation Specifications. | Class III | Teva North America |
| Aug 4, 2016 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count ... | Failed dissolution specifications - the out of specification result for dissolution was identifie... | Class III | Amerisource Health Services |
| Aug 4, 2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Genzyme Corporation / Genzyme Biosurgery |
| Aug 3, 2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa... | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydram... | Class III | Reckitt Benckiser LLC |
| Aug 3, 2016 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, ... | Failed Dissolution Specifications: Product did not meet dissolution specification at an intermedi... | Class III | Zydus Pharmaceuticals USA Inc |
| Aug 2, 2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 ... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Aug 2, 2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distribu... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Jul 27, 2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, ... | Failed impurities/degradation specifications: product was out of specification for unknown impuri... | Class III | Akorn, Inc. |
| Jul 15, 2016 | Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg p... | Failed Content Uniformity Specifications: out of specification test result for spray content unif... | Class III | Teva North America |
| Jun 29, 2016 | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5... | Failed Stability Specifications: The recalled lots did not meet the specification for color and p... | Class III | Hospira Inc. |
| Jun 28, 2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... | Class III | Golden State Medical Supply Inc. |
| Jun 27, 2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-c... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-cou... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 t... | Failed Dissolution Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-c... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 27, 2016 | Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count... | Failed Impurities/Degradation Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Jun 13, 2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... | Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Jun 10, 2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... | Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy... | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 7, 2016 | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in... | Subpotency: product assayed and found OOS for cyproheptadine | Class III | Lyne 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. |
| Jun 2, 2016 | Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05)... | Crystallization; complaints received by the manufacturer of crystals forming in product | Class III | Exact-Rx Inc |
| Jun 1, 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 1, 2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... | Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. | Class III | Aidarex Pharmaceuticals LLC |
| May 31, 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... | Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. | Class III | Teva North America |
| May 30, 2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... | Class III | Prinston Pharmaceutical Inc |
| May 28, 2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 ... | Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydro... | Class III | Par Pharmaceutical |
| May 26, 2016 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Ka... | Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc py... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| May 26, 2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz ... | Crystallization; Complaints that cream appears to have crystallized | Class III | Stratus Pharmaceuticals Inc |
| May 25, 2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... | Labeling: Incorrect or Missing Package Insert | Class III | Sandoz Inc |
| May 23, 2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... | Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 19, 2016 | Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Markete... | Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. | Class III | Galderma Laboratories, L.P. |
| May 19, 2016 | Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehring... | Failed Impurities/Degradation Specification; 9 month stability | Class III | West-Ward Columbus 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.