Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIBC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAPLET 24 CT SKU 914771 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIAD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OINTMENT CREAM 4 OZ SKU 902617 DESITIN MAXIMUM STRENGTH PASTE 4 OZ SKU 903097 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIBENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIFS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IINPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC OINTMENT 1 OZ SKU 999855 NPX TRPL ANTIBIOTIC PLS PAIN OINMNT 1 OZ SKU 901498 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIOrajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDOCTOR DANDRUF 2N1 SHAMP CLN APL 13.5FLOZ SKU 2005726 SUAVE 2N1 MENS CC ANTI DNDRF SHMP 28 FLOZSKU 2006512 MANE N TAIL 2 IN 1 ANTI DANDRUFF 12 FL OZ SKU 2024652 HEAD AND SOULDERS 2N1 SMOOTH SILKY 12.8 FL OZ SKU 2097272 DOCTOR MED DANDRUFF TREAT 11 FL OZ SKU 2005531 HEAD AND SOULDERS CLASSIC CLEAN SH 13.5 OZ SKU 2099110 DOCTOR DANDRUF 2IN1 SHAM DRYSCLP 13.5FL OZ SKU 2038805 HEAD AND SOULDERS 2IN 1 DRY SCALP 13.5 FL OZ SKU 2038366 HEAD AND SOULDERS 2IN 1 DRY SCALP SHAMPOO 23.7 FLOZ
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDISNEY LICENSED ANTI BAC WIPES 20 CT SKU 998908; ANTIBACTERIAL WIPES 40CT SKU 2007538 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIALEVE ANALGESIC BACK MUSCLE 24 CT SKU 999787 ALEVE PM CAPLETS 20 CT SKU 900442 ALEVE CAPLET 50 CT SKU 916980 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT LQ SPRY 5.3 FL OZ SKU 911077 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIFS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIMOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG CAPLET 100 CT SKU 902359 MOTRIN IB CAPLET 50 CT SKU 900604 GOOD SENSE IBUPROFEN IB CAPLET 100 CT SKU 913989 GOOD SENSE IBUPROFEN 200 MG SOFTGEL 20CT SKU 916994 ADVIL LIQUID GEL 40 CT SKU 916071 GOOD SENSE IBUPROF
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIReady in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 916986 TYLENOL 8HR MSL ACHE PAIN RD CAPLET 24 CT SKU 901155 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IISOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTSOAP LIQUID HAND SOAP FERSH CITRUS AB 11.25 FL OZ SKU 2005088 SPA SOAP HNDSP ANTBCTRL ULTR2X GLD 64 FL OZ SKU 2008290 DIAL FOAMING LHS SPRING WATER 7.5 FL OZ SKU 2044177 DAWN ULTRA ANTIBAC APL BLOSSOM 21.6 FLOZ SKU
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IISUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SKU 2004622 LADY SPEED STICK AP WILD FREESSIA 1.4OZ SKU 2005184 SUAVE AP DEOD POWDER 2.6 OZ 2PK SKU 2028126 SCRT IN SLD PWDR FRSH 2.1OZ 2PK SKU 2028363 LADY SPD STK AP INV PWDR 1.4OZ SKU 2028365 DEGREE INV SLD XBLST 2.7 OZ 2PK SKU 2028378 SECRET DEO INV SHWR FRSH 2.1 OZ SKU 2028538 SUAVE DEO TRPCL PARADISE 1.2 OZ SKU 2028544 SECRET DS WHTE PECH ARGN OIL SPRY 4.1 OZ SKU 2095889 SECRET DS WILD ROSE OIL SPR
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIHydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIListerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring Mint Antiseptic Mouth Rinse 8.5 OZ SKU 900273 Swan Original Antiseptic Mouth Rinse 8.5 OZ SKU 900938 Colgate Optic White Mouthwash 16 FL OZ SKU 999043 Crest Scope Classic Original Min Mouthwash 1 Ltr SKU 908109 Liste
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IICOLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 902143 CREST CMPLT SCOPE OUTLST PSTE 5.4OZ 2 PK SKU 902701 COLGATE TOTAL WHITENING TP 4.8 OZ SKU 902967 CREST 3D WHITE BRILLIANCE CHARCOAL 3.9 OZ SKU 903463 COLGATE BSPW GEL FROSTY MINT 6 OZ SKU 905026 ARM & HAMMER
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIDermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Lotion 5 OZ SKU 2005444 Aveeno Baby Daily Moistue Lotion 8 OZ SKU 900016 Vaseline Mens Extra Strength Body and Face Lotion 10 OZ SKU 2003674 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIBANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IIAMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IINovelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU 999330 Purell Hand Sanitizer Essentials 1 FL OZ SKU 2006819 Luxury Hand Sanitizer 16.9 FL OZ SKU 2007723 Suave Hand Sanitizer Lotion 3 FL OZ SKU 2096469 Purell Hand Sanitizer Original 6.5 FL OZ SKU 2095985 Purell Hand Sanitizer Soothing Aloe 6.5 Fluid Ounces SKU 2095986 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugAmneal Pharmaceuticals of New York, LLCClass IIDivalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Failed dissolution specifications.
- 2022-08-24FDA-DrugAkorn, IncClass IIPrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Defective Container: Product has incomplete induction seals.
- 2022-08-24FDA-DrugAire-Master of America IncClass IICommon Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIProtect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
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