Browse Drug Recalls

117 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 117 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 117 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Mar 31, 2023	Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R...	CGMP deviation: product outside labeled storage temperature requirements.	Class II	Family Dollar Stores, Llc.
Mar 31, 2023	Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ...	CGMP deviation: product outside labeled storage temperature requirements.	Class II	Family Dollar Stores, Llc.
Mar 31, 2023	Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI...	CGMP deviation: product outside labeled storage temperature requirements.	Class II	Family Dollar Stores, Llc.
Mar 31, 2023	Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count ...	CGMP deviation: product outside labeled storage temperature requirements.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Per...	cGMP deviation: Product held outside of appropriate temperature storage conditions.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT P...	cGMP deviation: Product held outside of appropriate temperature storage conditions.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net W...	cGMP deviation: Product held outside of appropriate temperature storage conditions.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 47...	cGMP deviation: Product held outside of appropriate temperature storage conditions.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT P...	cGMP deviation: Product held outside of appropriate temperature storage conditions.	Class II	Family Dollar Stores, Llc.
Aug 10, 2022	Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevent...	cGMP deviation: Product held outside of appropriate temperature storage 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	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	DULCOLAX 5 MG TABLET 25 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	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	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	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	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	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	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	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	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	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	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	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	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	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 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	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	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	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 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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STREN...	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.