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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DateProductReasonClassFirm
Sep 25, 2020 Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulde... Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Class I Wishgarden Herbs, Incorporated
Sep 25, 2020 Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Bould... Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Class I Wishgarden Herbs, Incorporated
Sep 25, 2020 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v... Failed Impurties/Degradation Specifications: out of specification results for an impurity for one... Class III VistaPharm, Inc.
Sep 25, 2020 Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO... Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Class I Wishgarden Herbs, Incorporated
Sep 24, 2020 Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Man... Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. Class III Legacy Pharmaceutical Packaging LLC
Sep 24, 2020 Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 ... Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine... Class III Leadiant Biosciences, Inc.
Sep 24, 2020 SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II AA PRODUCTS INC
Sep 23, 2020 RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500... CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Sep 17, 2020 Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), L... CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured ... Class II PD-Rx Pharmaceuticals, Inc.
Sep 17, 2020 NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx O... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
Sep 17, 2020 NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
Sep 17, 2020 Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic... Labeling: Product Contains Undeclared API; Incorrect formulation Class III Grato Holdings, Inc.
Sep 16, 2020 Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class II Calvin Scott & Company, Inc.
Sep 16, 2020 Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Or... Subpotent Drug Class III Arbor Pharmaceuticals Inc.
Sep 16, 2020 Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhal... Defective Delivery System: Sustained trend of failure to dispense complaints. Class II Perrigo Company PLC
Sep 16, 2020 Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc.... cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class II Calvin Scott & Company, Inc.
Sep 16, 2020 Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class II Calvin Scott & Company, Inc.
Sep 11, 2020 Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactu... Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... Class II Genesis Partnership Company SA
Sep 11, 2020 Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manuf... Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... Class II Genesis Partnership Company SA
Sep 11, 2020 Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8... CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... Class II Genesis Partnership Company SA
Sep 11, 2020 Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guate... CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... Class II Genesis Partnership Company SA
Sep 11, 2020 Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon ... CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... Class II Genesis Partnership Company SA
Sep 9, 2020 Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9... Class III PAI Holdings, LLC. dba Pharmaceutical Associate...
Sep 9, 2020 M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... Class I MEDEK LLC
Sep 9, 2020 Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ... Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc... Class III P & L Developments, LLC
Sep 4, 2020 Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal... Failed Stability Specifications: Below specification result for buprenorphine release rate. Class II Teva Pharmaceuticals USA
Sep 3, 2020 Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL... CGMP Deviations Class II Akorn, Inc.
Sep 3, 2020 Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99... Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an... Class I CORGIOMED LLC
Sep 3, 2020 bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle... CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed... Class II AJR TRADING LLC
Sep 2, 2020 pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositori... Marketed without an Approved NDA/ANDA. Class II pH-D Feminine Health
Sep 2, 2020 Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyr... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sa... CGMP Deviations: Product manufactured in same facility where product was found to contain acetald... Class II Charles Paint Research Inc
Sep 2, 2020 Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyr... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sa... CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits. Class II Charles Paint Research Inc
Sep 2, 2020 Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyron... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) ... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 1, 2020 Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st... Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv... Class I The Protein Shoppe
Aug 25, 2020 Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 F... Lack of CGMPs: Class II Asiaticon, SA de CV
Aug 25, 2020 Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, ... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levoth... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 7... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Le... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 1... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levo... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4)... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.

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.