Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 23, 2022 | PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dolla... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily s... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mou... | 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 | DRX FIBER CAPSULES 100 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 | Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Famil... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | PREFERRED URINRY PN RLF MAX STRNGTH 12 CT distributed to specific Family Doll... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC O... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family D... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FLEET GLYCERIN SUPPOSITORIES 50 CT distributed to specific Family Dollar Stor... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Store... | 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 | Orajel Cold Sore Pain Cream 1.25 fl. 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 OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | PEPCID COMPLETE CHEWABLE TAB BERRY 8CT SKU 903365 PEPCID AC MAXIMUM STRENGT... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | QP LAXATIVE BISACODYL 5 MG TABLET 50 CT SKU 902449 QP WOMEN LAXATIVE BISCOD... | 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 | 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 | JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAP... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | VICKS VAPORUB 1.76 OZ SKU 919667 VICKS VAPOR RUB LAVENDER 1.76 OZ 999813 ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 throug... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Store... | 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 | DOCTOR TEALS PURE EPSOM SALT UNSCENTED 6 LBS SKU 999355 Ready in case EPSOM... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASESLEEP AID SOFT GEL 32 CT SKU 901457 READY IN CASE SLEEP AID 64 ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIE... | 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 | DR SCHOLLS CLR AWAY LIQ WART REMVR 20CT SKU 998384 DR SCHOLLS CALLUS REMOVE... | 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 | GOOD SENSE HEMORRHOID OINTMENT 2 OZ SKU 910325 GOOD SENSE HEMORRHOIDAL WIPE... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ZARBEES NTRL CHLD COUGH MUCUS GRP 4 FL OZ distributed to specific Family Doll... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/3... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG T... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167... | 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.