Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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Date	Product	Reason	Class	Firm
Jul 3, 2020	Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bott...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Granules Pharmaceuticals Inc
Jul 2, 2020	Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL...	CGMP Deviations	Class II	AAA Cosmetica, SA de CV
Jul 2, 2020	Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle,...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-0...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Libe...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finast...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPha...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446...	Labeling: Label Error on Declared Strength	Class II	Edge Pharma, LLC
Jul 2, 2020	Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, Maste...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterP...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 ...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL...	Chemical Contamination: Product contains methanol.	Class I	AAA Cosmetica, SA de CV
Jul 2, 2020	Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPh...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx o...	Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.	Class II	Lupin Pharmaceuticals Inc.
Jul 2, 2020	Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterP...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richm...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 2, 2020	Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0...	Lack of Processing Controls (lack of assurance of conformity to specifications).	Class II	MasterPharm LLC
Jul 1, 2020	Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), F...	Microbial contamination of non-sterile products: positive microbial contamination in product.	Class I	Spartan Chemical Co Inc
Jul 1, 2020	Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to...	CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ...	Class II	Preferred Pharmaceuticals, Inc.
Jun 29, 2020	Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka...	FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur...	Class II	RemedyRepack Inc.
Jun 29, 2020	Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutane...	Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber ...	Class II	EMD Serono, Inc.
Jun 29, 2020	Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti...	Chemical Contamination: Presence of Undeclared Methanol	Class I	Transliquid Technologies, LLC
Jun 25, 2020	Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr...	CGMP Deviations: Product was found to be below the label claim for ethanol content and the presen...	Class II	POLARIZED LLC
Jun 24, 2020	Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX O...	Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia...	Class I	Medichem S.A.
Jun 23, 2020	Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl...	Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp...	Class III	VistaPharm, Inc.
Jun 23, 2020	ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro...	Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides	Class I	CareFusion 213, LLC
Jun 23, 2020	BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an...	Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides	Class I	CareFusion 213, LLC
Jun 23, 2020	Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,...	Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp...	Class III	VistaPharm, Inc.
Jun 23, 2020	ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro...	Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides	Class I	CareFusion 213, LLC
Jun 23, 2020	Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott...	cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri...	Class III	Biogen MA Inc.
Jun 23, 2020	All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%,...	Chemical Contamination: Product contains undeclared methanol.	Class I	Itech 361 LLC
Jun 22, 2020	Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr...	Chemical Contamination: Product contains undeclared methanol.	Class I	UVT INC
Jun 18, 2020	Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, ...	Chemical contamination: product contains elevated levels of undeclared lead.	Class I	MICHIGAN HERBAL REMEDIES
Jun 18, 2020	Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distri...	Chemical contamination: product contains elevated levels of undeclared lead.	Class I	MICHIGAN HERBAL REMEDIES
Jun 18, 2020	Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, D...	Chemical contamination: product contains elevated levels of undeclared lead.	Class I	MICHIGAN HERBAL REMEDIES
Jun 18, 2020	Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles...	Chemical contamination: product contains elevated levels of undeclared lead.	Class I	MICHIGAN HERBAL REMEDIES

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.