Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
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 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 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, 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 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 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 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 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 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 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 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 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 Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL... CGMP Deviations Class II Akorn, Inc.
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, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) ... CGMP Deviations Class II Preferred Pharmaceuticals, 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 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, 1.5 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 manufactured in same facility where product was found to contain acetald... Class II Charles Paint Research Inc
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 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 WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000... 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) 15.75 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 Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 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 V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC... Lack of CGMPs: Class II Asiaticon, SA de CV
Aug 25, 2020 Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 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 Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 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 Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 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 Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 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, 3/4 Grain (48.75 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, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000... CGMP Deviations: manufactured under the same conditions as those found to be subpotent. Class II RLC Labs Inc.
Aug 25, 2020 Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, L... Subpotent Drug: FDA analysis found product to be subpotent Class I RLC Labs Inc.
Aug 25, 2020 WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 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 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.
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) 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, 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) 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, 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 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 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 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 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, 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 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 Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 F... Lack of CGMPs: Class II Asiaticon, SA de CV
Aug 24, 2020 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... Sub-Potent Drug: Out of specification test results for potency (below specification). Class II Teva Pharmaceuticals USA
Aug 24, 2020 Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (6... Failed Dissolution Specifications Class II Strides Inc.
Aug 24, 2020 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... CGMP deviations; there is a possibility that some bottles in these lots may have the active ingre... Class II Teva Pharmaceuticals USA

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.