Browse Drug Recalls
1,032 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,032 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 1,032 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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. |
| 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 24, 2016 | Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Man... | Superpotent drug: Out of specification test result for assay during stability testing. | Class II | Teva North America |
| 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 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 |
| May 17, 2016 | Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL b... | Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability | Class II | Akorn, Inc. |
| May 9, 2016 | Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufac... | Failed impurities/degradation specifications: Out of specification results noticed in related sub... | Class II | Zydus Pharmaceuticals USA 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 14, 2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Feb 12, 2016 | Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Myl... | Failed Dissolution Specifications; three month stability time point. | Class II | Mylan Pharmaceuticals Inc. |
| Feb 11, 2016 | sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp condition... | Subpotent Drug: failed at the 3 and 6 month stability time points. | Class III | J. Strickland and Co |
| Feb 11, 2016 | Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only... | Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceedi... | Class II | Sun Pharma Global Fze |
| Feb 5, 2016 | Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By... | Failed Impurities/Degradation Specifications: Out of specification test results for impurities du... | Class II | Teva Pharmaceuticals USA |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 26, 2016 | Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Di... | Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) | Class III | Amerisource Health Services |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Dec 31, 2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ... | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Class III | Sandoz Inc |
| Dec 17, 2015 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 f... | Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result de... | Class III | Bio-pharm, Inc. |
| Dec 15, 2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottl... | Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. | Class III | Morton Grove Pharmaceuticals, Inc. |
| Nov 12, 2015 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... | Failed Impurities/Degradation Specifications: High out of specification test result for impuritie... | Class II | Teva Pharmaceuticals USA |
| Oct 21, 2015 | RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m... | Failed Stability Specifications: Out of Specification results obtained for preservative butylpara... | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Phar... |
| Sep 29, 2015 | Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,... | Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation p... | Class III | Hospira Inc. |
| Aug 21, 2015 | HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, R... | Stability Data Does Not Support Expiry | Class II | Cantrell Drug Company |
| Aug 21, 2015 | HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), ... | Stability Data Does Not Support Expiry | Class II | Cantrell Drug Company |
| Aug 19, 2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 m... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Tot... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in ... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 ... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 1... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosag... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharma... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, ... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 m... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, ... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in s... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
| Aug 19, 2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL i... | Stability data does not support expiry. | Class II | Pharmakon Pharmaceuticals |
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.