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Browse Drug Recalls

420 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 420 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 420 FDA drug recalls in VA.

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DateProductReasonClassFirm
Dec 27, 2022 Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Se... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sent... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LI... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curli... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pu... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, u... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 ... Lack of sterility assurance Class II Sentara Infusion Services
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 29, 2022 Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manuf... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Ba... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per ... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restor... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propyle... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories pe... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Red... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B su... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alco... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, M... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporar... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhal... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022 Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine... CGMP Deviations: products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
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.

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.