Browse Drug Recalls
3,371 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,371 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 3,371 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY... | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | Class II | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Jul 29, 2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | Class II | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Jul 15, 2021 | Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendsh... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 15, 2021 | Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne ... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 14, 2021 | Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRU... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzo... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzon... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jun 30, 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... | CGMP Deviations: Does not meet monograph for denaturant. | Class II | Cascade Kelly Holdings LLC |
| Jun 30, 2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-ste... | CGMP Deviations: Does not meet monograph for denaturant. | Class II | Cascade Kelly Holdings LLC |
| Jun 29, 2021 | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, R... | cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cak... | Class II | Eli Lilly & Company |
| Jun 16, 2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottl... | cGMP deviations: Discolored acetaminophen | Class II | Spirit Pharmaceuticals |
| Jun 10, 2021 | Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured... | CGMP Deviations | Class II | CIPLA |
| Jun 9, 2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Jun 9, 2021 | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... | Class II | Pfizer Inc. |
| Jun 9, 2021 | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... | Class II | Pfizer Inc. |
| Jun 1, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS INC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alco... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... | Class II | Global Sanitizers LLC |
| May 11, 2021 | ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| Apr 15, 2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medi... | cGMP deviations | Class II | Grace Healthcare Medical, Inc |
| Mar 29, 2021 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Conten... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Conte... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Content... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.7... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 25, 2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-... | CGMP Deviaitons | Class II | Cosette Pharmaceuticals, Inc. |
| Mar 19, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| Mar 15, 2021 | Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health 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.