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Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
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 ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0... 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 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 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 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 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.
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 AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/202... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SK... 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 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 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 COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ ... 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 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 ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar St... 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 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 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 READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN REL... 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 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 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 DISNEY LICENSED ANTI BAC WIPES 20 CT SKU 998908; ANTIBACTERIAL WIPES 40CT S... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU ... 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 QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 HYLANDS 4KIDS COLD N MUCUS RELIEF 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 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 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 DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GE... 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 Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Loti... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SK... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ZZZQUIL NIGHT PAIN BERRY 12 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 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 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 SWAN POVIDONE 4 FL OZ 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 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 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 REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT S... 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 NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar... 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 AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dolla... 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.

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.