Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 15, 2022 | Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) ... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutio... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jun 29, 2022 | A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Ba... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories pe... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restor... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manuf... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B su... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Red... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhal... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propyle... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alco... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporar... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, M... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per ... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 23, 2022 | MIDOL COMPLETE CAPLET 16 CT SKU 913028 QP MENSTRUAL RELIEF COMPLETE CAPLET ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL O... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | CARMEX DAILY CARE CHERRY SPF 15 0.35 OZ SKU 901842 CARMEX LIP BALM JAR 0.25... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Famil... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BLISTEX LIP MEDEX 0.25OZ SKU 906120 BLISTEX LIP MEDEX POT 0.38 OZ SKU 99885... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AN... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MY CHOICE LEVONORGESTREL TABLET distributed to specific Family Dollar Stores ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRA... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | SWAN CALAMINE LOTION 6 FL OZ distributed to specific Family Dollar Stores 04/... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | DOCTOR DANDRUF 2N1 SHAMP CLN APL 13.5FLOZ SKU 2005726 SUAVE 2N1 MENS CC ANT... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar St... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ASPERCREME WITH LIDOCAINE CREME 1.75 OZ SKU 999852 ICY HOT LIDOCAINE CREAM ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | VASELINE ECZEMA CALMING THERPY CRM 6.8 OZ distributed to specific Family Doll... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 M... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dolla... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 0... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SP... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stor... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/202... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
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.