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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
Aug 10, 2022 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... cGMP Deviations: deviations leading to potential cross-contamination. Class II Nephron Sc Inc
Aug 10, 2022 PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center 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 Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 8, 2022 Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a)... CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. Class II Midlab Incorporated
Aug 8, 2022 Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride ... CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. Class II Midlab Incorporated
Jul 28, 2022 Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured ... CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. Class II Lupin Pharmaceuticals Inc.
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... CGMP Deviations Class II Vi-Jon, LLC
Jul 15, 2022 Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... CGMP Deviations Class II Vi-Jon, LLC
Jul 15, 2022 Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutio... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) ... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) pe... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) ... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F... CGMP Deviations; Class II Vi-Jon, LLC
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Jun 23, 2022 STYE EYE OINTMENT 0.125 OZ 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 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 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 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 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 DRX FIBER CAPSULES 100 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 QP MOTION SICKNESS TABLET 8 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 NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC O... 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 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 PREFERRED URINRY PN RLF MAX STRNGTH 12 CT distributed to specific Family Doll... 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 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 ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL O... 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 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.

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.