Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syrin... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL),... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ke... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, pac... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center 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 Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Jun 29, 2022 Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant ... Failed Dissolution Specifications Class III Eco Lips, Inc
Jun 29, 2022 Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, R... Defective Container: Recall of these batches has been initiated due to complaints of difficult t... Class II Glenmark Pharmaceuticals Inc., USA
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 Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, H... Failed Dissolution Specifications Class III Eco Lips, Inc
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 Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx ... Defective Container: Recall of these batches has been initiated due to complaints of difficult t... Class II Glenmark Pharmaceuticals Inc., USA
Jun 29, 2022 Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bot... Failed Tablet/Capsule Specification : Capsule breakage Class III Glenmark Pharmaceuticals Inc., USA
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 Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... Superpotent Drug: Out of specification assay result was obtained during stability testing. Class II Teva Pharmaceuticals USA Inc
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 28, 2022 Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, pa... Cross Contamination With Other Products: Product is cross contaminated with low levels of isoprop... Class II Vi-Jon, LLC
Jun 27, 2022 Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ... Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. Class II Loud Muscle Science
Jun 27, 2022 Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW... Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. Class II Loud Muscle Science
Jun 27, 2022 Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharm... Subpotent and Superpotent Drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Jun 27, 2022 Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 27, 2022 Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. Class II Loud Muscle Science
Jun 27, 2022 Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ... Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... Class I Loud Muscle Science
Jun 27, 2022 Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW... Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... Class I Loud Muscle Science
Jun 27, 2022 Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... Class I Loud Muscle Science
Jun 24, 2022 Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distribute... Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affix... Class II Vi-Jon, LLC
Jun 24, 2022 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Customer complaints received for ripping patches and tight release/adh... Class II Noven Pharmaceuticals Inc
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.

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.