Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Jun 23, 2022 ZARBEES NTRLS BABY CGH MUCUS GRP 2 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 FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar... 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 ALEVE ANALGESIC BACK MUSCLE 24 CT SKU 999787 ALEVE PM CAPLETS 20 CT SKU 900... 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 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 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 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 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 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 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 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 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 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 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 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 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 GOOD SENSE LICE SHAMPOO 6FL OZ 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 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 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 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 DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OINTMENT CREAM 4 OZ SK... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 EXCEDRIN MIGRAINE CAPLET 24 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 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 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 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 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 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 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 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 SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AN... 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 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 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 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 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 READY IN CASE MICON 7 DAY 1.59 OZ SKU 939212 READY IN CASE MICON 3 DAY COMB... 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 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 GOOD SENSE SORE THROAT SPRAY CHERRY 6 FL OZ distributed to specific Family Do... 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 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 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 21, 2022 Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... cGMP - Water leakage Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 10, 2022 Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Jun 7, 2022 CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dext... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare 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.