Browse Drug Recalls
18,008 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,008 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 18,008 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 | 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 | Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... | Superpotent Drug: Out of specification assay result was obtained during stability testing. | Class II | Teva Pharmaceuticals USA Inc |
| 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 | 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 28, 2022 | Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, pa... | Cross Contamination With Other Products: Product is cross contaminated with low levels of isoprop... | Class II | Vi-Jon, LLC |
| Jun 27, 2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... | Class I | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... | Class I | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... | Class I | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
| Jun 27, 2022 | Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 27, 2022 | Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharm... | Subpotent and Superpotent Drug | Class I | Valor Compounding Pharmacy, Inc DBA Valor Comp... |
| Jun 27, 2022 | Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
| Jun 24, 2022 | Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distribute... | Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affix... | Class II | Vi-Jon, LLC |
| Jun 24, 2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: Customer complaints received for ripping patches and tight release/adh... | Class II | Noven Pharmaceuticals Inc |
| 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 | MYLANTA MAX STRENGTH CLASSIC FLVR 12 FLOZ distributed to specific Family Doll... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 9... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5... | 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 | RIC STOOL SOFTENER SOFTGEL 100 CT SKU 917000 RIC STOOL SOFTNER 100 CT SKU 9... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific... | 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 | 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 | 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 | QP MOTION SICKNESS TABLET 8 CT 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 | 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 | 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 | 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 | 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. |
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.