Browse Drug Recalls
114 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 114 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 114 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 29, 2018 | Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Dec 13, 2017 | INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... | Failed Stability Specifications: Product stability testing results did not meet specifications fo... | Class II | ALLERGAN |
| Nov 20, 2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... | Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... | Class II | Teva Pharmaceuticals USA |
| Oct 25, 2017 | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... | Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... | Class II | Teva Pharmaceuticals USA |
| Sep 26, 2017 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... | Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. | Class II | The Harvard Drug Group |
| Sep 5, 2017 | Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... | Class II | Teva Pharmaceuticals USA |
| May 31, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... | Class I | Teva Pharmaceuticals |
| Feb 28, 2017 | Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... | CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. | Class III | G & W Laboratories, Inc. |
| Feb 7, 2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... | Class III | Actavis Inc |
| Jan 30, 2017 | Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... | Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th... | Class II | Actavis Inc |
| Jan 12, 2017 | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Actavis Inc |
| Oct 13, 2016 | AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Indi... | Presence of Foreign Tablets/Capsules | Class III | Amerisource Health Services |
| Oct 6, 2016 | NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and d... | Presence of Foreign Tablets/Capsules | Class III | Actavis Elizabeth 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 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 |
| 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 |
| Jul 11, 2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... | Failed Dissolution Specifications | Class II | Actavis Inc |
| Jun 30, 2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufact... | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... | Class II | Actavis Inc |
| Mar 16, 2016 | Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL... | Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-sp... | Class III | Actavis Pharma Inc |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Feb 16, 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class II | Actavis Elizabeth LLC |
| Sep 25, 2015 | Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. | Class II | Actavis Laboratories, FL, Inc. |
| Jun 23, 2015 | Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured... | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | Class III | Actavis Laboratories, FL, Inc. |
| Jun 4, 2015 | Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... | Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... | Class III | Actavis Inc |
| Apr 14, 2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis... | Subpotent Drug: Flurandrenolide is subpotent. | Class III | Actavis Laboratories |
| Mar 26, 2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... | Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... | Class III | Actavis Laboratories, FL, Inc. |
| Feb 12, 2015 | Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx... | Subpotent Drug | Class II | Actavis Inc |
| Feb 12, 2015 | Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx... | Subpotent Drug | Class II | Actavis Inc |
| Feb 10, 2015 | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles,... | Failed Dissolution Specifications | Class II | Actavis Elizabeth LLC |
| Dec 15, 2014 | Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45... | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... | Class II | Actavis Elizabeth LLC |
| Dec 15, 2014 | Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14... | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... | Class II | Actavis Elizabeth LLC |
| Dec 15, 2014 | Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactu... | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... | Class II | Actavis Elizabeth LLC |
| Sep 26, 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Presence of split or broken tablets. | Class II | Actavis Laboratories, FL, Inc. |
| Aug 25, 2014 | Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only... | Subpotent Drug | Class II | Actavis Inc |
| Aug 25, 2014 | Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only... | Subpotent Drug | Class II | Actavis Inc |
| May 16, 2014 | Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsul... | Subpotent Drug. | Class II | Actavis Inc |
| Apr 24, 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Class II | Actavis Laboratories, FL, Inc. |
| Apr 24, 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Class II | Actavis Laboratories, FL, Inc. |
| Feb 10, 2014 | Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured ... | Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for... | Class II | Actavis Elizabeth LLC |
| Feb 7, 2014 | Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use... | Subpotent Drug: Drug potency was compromised during shipment. | Class III | Actavis |
| Feb 4, 2014 | Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, ... | Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. | Class II | Actavis Elizabeth LLC |
| Dec 20, 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. | Class II | Watson Laboratories, Inc.-(Actavis) - Florida |
| Dec 9, 2013 | Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (ND... | Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial... | Class II | Actavis Inc |
| Nov 15, 2013 | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... | Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. | Class III | Actavis Inc |
| Nov 6, 2013 | Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth L... | Subpotent Drug: During routine stability testing one tablet was found with tablet weight below sp... | Class II | Actavis Elizabeth LLC |
| Oct 9, 2013 | Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Onl... | Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below sp... | Class II | Actavis Elizabeth LLC |
| Aug 23, 2013 | CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL ... | CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was... | Class II | Central Shared Services dba Parallon |
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.