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 |
|---|---|---|---|---|
| May 24, 2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b... | Presence of foreign substance: The recall was initiated due to black particles being observed whi... | Class III | Shionogi Inc. |
| May 24, 2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Class III | Shionogi Inc. |
| May 9, 2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... | Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... | Class III | Strides Pharma INC |
| May 1, 2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... | Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... | Class II | Allergan Sales, LLC |
| Apr 27, 2017 | Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... | Defective Delivery System: Out of specification for peel force from the release liner specificati... | Class III | Noven Pharmaceuticals, Inc. |
| Mar 28, 2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... | Failed Stability Specifications | Class III | Teva Pharmaceuticals USA |
| Mar 28, 2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... | Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 15, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... | Failed Dissolution Specifications; 9 month long term stability | Class II | Zydus Pharmaceuticals USA Inc |
| Feb 17, 2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications: low out of specification dissolution results found during stab... | Class III | Teva Pharmaceuticals USA |
| Feb 7, 2017 | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and ... | Class II | 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 13, 2017 | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... | Failed Stability Specifications: confirmed out of specification results obtained during refrigera... | Class II | AbbVie Inc. |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| 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. |
| Dec 22, 2016 | TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:... | Failed Stability Specifications | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Phar... |
| Dec 21, 2016 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... | Subpotency: due to a low, out of specification test result for assay during stability testing. | Class II | Teva Pharmaceuticals USA |
| Dec 20, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... | Failed Dissolution Specifications; 18 month stability time point | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 20, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... | Failed Dissolution Specifications; 18 month stability time point | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 6, 2016 | INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only,... | Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed vari... | Class III | Cipher Pharmaceuticals US LLC |
| Nov 22, 2016 | PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... | Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. | Class III | Pfizer Inc. |
| Nov 17, 2016 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5... | Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 14, 2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... | Failed Stability Specifications; out-of specification value for homogeneity / phase separation. | Class II | Akorn Inc |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Oct 28, 2016 | KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,... | Failed Stability Specifications: Low Out of Specification results for alcohol content. | Class III | Sun Pharmaceutical Industries, Inc. |
| Oct 27, 2016 | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... | Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... | Class III | Amerisource Health Services |
| 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. |
| Oct 3, 2016 | Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... | Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... | Class II | West-Ward Pharmaceuticals Corp. |
| Sep 22, 2016 | PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pha... | Failed Impurities/Degradation Specifications: out of specification test results for impurities du... | Class III | Teva Pharmaceuticals USA |
| Sep 22, 2016 | PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pha... | Failed Impurities/Degradation Specifications: out of specification test results for impurities du... | Class III | Teva Pharmaceuticals USA |
| Sep 22, 2016 | PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pha... | Failed Impurities/Degradation Specifications: out of specification test results for impurities du... | Class III | Teva Pharmaceuticals USA |
| Sep 13, 2016 | Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals ... | Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Mod... | Class II | Taro Pharmaceuticals, Inc. |
| Sep 13, 2016 | Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals ... | Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Mod... | Class II | Taro Pharmaceuticals, 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 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 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 |
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.