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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 3,501–3,520 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

BENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

NPX 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

ORAJEL 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Orajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

DOCTOR 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 SKU 2005504 DOCTOR DANDRUFF 2N1 SHAMPOO 13.5FL OZ SKU 2038806 DOCTOR SHAMPOO T GEL 8.5 FL OZ SKU 2038935 DOCTOR 2N1 DANDRUFF CLSC 23.7FLOZ SKU 2005121 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

DISNEY 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

ALEVE 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

DR 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

MOTRIN 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 IBUPROFEN PM 200 MG 20 CT SKU 917004 ADVIL PM CAPLET 20CT SKU 913010 GOOD SENSE IBUPROFEN TABLET 100 CT SKU 913991 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Specifically:

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Ready 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

SUAVE 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 SPRAY 4.1 OZ SKU 2095896 DOVE ADVANCED COOL ESSENTIALS 2.6OZ SKU 2099968 OLD SPICE RED ZONE DEO SWAGGER 3OZ SKU 2005168 OLD SPICE HE FRESH DEO 2.4OZ 2PK SKU 2007730 SECRET OUTLAST CLEAN LVNDR GEL 2.6OZ SKU 2098900 OLD SPICE WC IS BEARGLOVE 2.6OZ SKU 2099254 DEGREE FMAL BLCK WHT PURERN DRYSPRY3.8OZ SKU 2003471 DEGREE EXTREME BLAST IS 2.7 OZ SKU 2005214 SECRET FRESH IS COCOA BUTTER 2.6OZ SKU 2007898 SECRET OUTLAST IS COMPLETELY CLEAN 2.6OZ SKU 2001333 DEGREE ML INVIS SLD COOL RUSH 1.7OZ SKU 2002557 OLD SPICE RZ SWAGGER 2.6 OZ SKU 2004512 DOVE AP INV SLD FRESH 1.6 OZ SKU 2028253 DEGREE FOR WOMEN IS BW PURE RAIN 2.6 OZ SKU 2096622 DEGREE BLCK WHIT PURE CLN DRY SPRY 3.8 OZ SKU 2003471 DEGREE MEN INV SLD SPORT TWIN 2.7 OZ 2PK SKU 2001309 SECRET INVS SLD PWDR FRSH 2.1 OZ SKU 2028310 DOVE ADVANCED CARE IS COCONUT 2.6 OZ SKU 2006902 SECRET FRESH EXP PARIS ROSE GEL 2.6 OZ SKU 2098479 OLD SPICE FIJI 2.6OZ SKU 2001336 SECRET AP STICK FRSH PWD 1.7OZ SKU 2028566 DOVE MEN AP INV SLD XTRA FRSH 2.7 OZ SKU SECRET OUTLAST CLR GEL PWDR PROTEC 2.6OZ SKU 2044343 DOVE CARING COCONUT DRY SPRAY 3.8OZ SKU 2097527 DOVE CLR FNSH 100 CLRS DRY SPR 3.8FLOZ SKU 2098905 AXE AP INV SLD DK TEMPT 2.7OZ SKU 2028222 DOVE DRY SPRAY COOL ESSENTIALS 3.8 OZ L2 SKU 2006098 DEGREE FMLE INV SLD TWN PWDR 2.6 OZ 2PK SKU 2001311 OLD SPICE HE PLAYMAKER 2.4 OZ SKU 2004835 GIL CLEAR GEL COOL WAVE 2.85 OZ 2PK SKU 2005220 DEGREE WMNS SEXY INTRIGUE 2.6 OZ SKU 2028194 MENNEN SPEED STCK AP INV SLD FRSH 1.8 OZ SKU 2028249 DOVE INV SLD POWDER 1.6 OZ SKU 2028255 DEGREE AP INV SLD XBLAST 1.7 OZ SKU 2028257 AH ULTRAMAX INV SLD FRSH SCT 1 OZ SKU 2028315 POWER STICK LADY AP POWDER FRESH 1.7 OZ SKU 2044190 DOVE MENS INV SOLID CLEAN COMFORT 1.7 OZ SKU 2097528 AXE APOLLO INV SOLID DEODORANT 1.7 OZ SKU 2097534 DEGREE AP INV SLD FRESH 2.6OZ SKU 2028218 SUAVE AP INV SLD TRPCL PARDSE 2.6 OZ SKU 2004752 DEGREE AP INV SLD SHOWR 1.6 OZ SKU 2028258 SUAVE MENS ACTIVE SPORT 2.7OZ SKU 2098472 OLD SPICE INV SLD KRAKENGARD 2.6OZ SKU 2098901 AXE ANARCHY INVISIBLE SOLID 2.7 OZ SKU 2005211 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

COLGATE 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 COMPLETE CARE BKS PRX TP 6 OZ SKU 905028 COLGATE BSPW PASTE BRISK MINT 2.5 OZ SKU 905703 COLGATE BSPW PASTE BRISK MINT 6 OZ SKU 907121 CREST BS N PX WHTE TUBE FRESH MINT 5.7 OZ SKU 907125 COLGATE SPARKLING WHITE MINT ZING 2.5 OZ SKU 907151 ARM & HAMMERADV WHITE TP 4.3 FL OZ SKU 907766 COLGATE MAX FRESH COOL MINT TP 6 OZ SKU 907839 CREST COMPLETE SCOPE OUTLAST TP 5.4 OZ SKU 907872 COLG MAX FRESH COOL MINT TP 6.3 OZ 3PK SKU 998200 COLGATE OW STAIN FIGHTR TOOTHPASTE 4.2 OZ SKU 998278 COLGATE MAX FRESH WHTNING CHRCOAL TP 6 OZ SKU 998881 COLGATE CHARCOAL TP 2.2 OZ SKU 998902 CREST 3D WHITE STAIN ERASER 3.1OZ TWN PK SKU 999286 COLGATE ESSENTIALS CHARCOAL PASTE 4.6 OZ SKU 999318 COLGATE TOTAL CLEANMINT TOOTHPASTE 4.8 OZ SKU 999498 COLGATE OW STAINFIGHTERCLEANMNT4.2OZ 2PK SKU 999633 COLGATE OW STAIN FIGHTER CLEAN MNT 4.2 OZ SKU 999750 COLGATE DEEP CLEAN GEL TOOTHPASTE 2.5 OZ SKU 999916 CREST TARTAR PROTECTION PASTE 5.7 OZ SKU 900353 COLGATE TOTAL WHITENING GEL 4.8OZ 2 PK SKU 903152 CREST CAVITY PROTECTION PASTE 5.7 OZ SKU 907327 CREST PRO HEALTH WHITENING GEL TP 4.6 OZ SKU 999760 AIM CAVITY PRTCT MINT GEL 4.5 OZ SKU 999910 CREST 3D WHITE RADIANT MINT 2.7 OZ SKU 907160 CR FRESH WHT PEP GIM 2.4 OZ SKU 900791 COLGATE SENSITIVE WHITENING PASTE 6 OZ SKU 901677 COLGATE TRIPLE ACTION 2.5 OZ SKU 907170 COLGATE OW STAIN PREVENTION TP 2.1 OZ SKU 998277 CREST 3D WHITE CHARCOAL 2.7 OZ SKU 999282 ARM & HAMMER PEROXICARE MINT PASTE 6 OZ SKU 999937 CREST ANTI CAVITY PASTE 2.4 OZ SKU 907165 CLOSE UP CINN RED GEL TP 4 OZ SKU 907220 COLGATE BSPW GEL TP 6OZ 3PK; SKU 902966 COLGATE TOTAL WHTN GEL TP 4.8 OZ SKU 906406 COLGATE CAVITY PROTECTION 6 OZ SKU 907329 COLGATE MAX FRSH ADV WHTN CLN MNT TP 6 OZ SKU 998257 CG OW SF MINT PASTE 2.0 OZ SKU 999723 COLGATE KIDS JUNIOR BUBBLE FRUIT 3.5 OZ SKU 900592 CREST BKING SDA PEROXIDE WHTNG TP 2.4 OZ SKU 907865 CREST KIDS SPRKL TPST 2.2 OZ SKU 901243 CREST 3D WHITE ARTIC FRESH 2.7 OZ SKU 905045 COLGATE RENEWAL GUM REVITALIZE TP 3 OZ SKU 998741 ULTRA BRITE ADV WHITENING TP 6 OZ SKU 902134 COLGATE BASE DEEP CLEAN GEL 6 OZ SKU 900728 COLGATE TOTAL WHTN PASTE TP 4.8OZ 2PK SKU 901784 SENSODYNE PRO NAMELGENTLE WHT 2.7 OZ SKU 902124 SWAN ULTRA CLEAN ARCTIC MINT 33.8 FL OZ SKU 902840 CREST 3DW ULTRA WHITE 3 OZ SKU 903453 COLGATE KIDS TP ASRTD CHARACTERS 4.6 OZ SKU 905517 PEPSODENT ORIGINAL TP 4.5 OZ SKU 907136 SENSODYNE EXTRA WHTEN TP 2.7 OZ SKU 907781 CREST PSTE DNSIFY DAILY WHITENING 4.1 OZ SKU 998268 ORAJEL PP FLUORIDE TOOTHPASTE 4.2 OZ SKU 998397 CREST 3D WHITE BRILLIANCE THPASTE 2.7 OZ SKU 998730 TOM'S KIDS STRAWBERRY ANTICAVITY 5.1 OZ SKU 999099 CREST 3D WHITE STNERSR ICY CLN MNT 3.1 OZ SKU 999285 SENSODYNE COMPLETE FRESH PASTE 3.4 OZ SKU 902363 CREST PRO HEALTH DEEP CLEAN TP 3.5 OZ SKU 903245 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Dermasil 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

BANANA 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 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Novelty 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.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Divalproex 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

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed dissolution specifications.
Recall initiated
July 27, 2022
Reported by FDA
August 31, 2022
Distribution
USA nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

PrednisoLONE 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

by Akorn, Inc

Reason
Defective Container: Product has incomplete induction seals.
Recall initiated
August 1, 2022
Reported by FDA
August 24, 2022
Distribution
Nationwide USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.