Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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. |
| 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 | 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 | 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 | 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 | 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 | ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SP... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Fa... | 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 | 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 | Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAP... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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. |
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.