Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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
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, 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 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) 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 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 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 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 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) 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 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, 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 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 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, 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, 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 Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 F... Lack of CGMPs: Class II Asiaticon, SA de CV
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 ... Sub-Potent Drug: Out of specification test results for potency (below specification). Class II Teva Pharmaceuticals USA
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
Aug 24, 2020 Cephalexin for Oral Suspension, USP 125 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
Aug 19, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx O... CGMP Deviations Class II BAYSHORE PHARMACEUTICALS
Aug 19, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx ... CGMP Deviations Class II BAYSHORE PHARMACEUTICALS
Aug 18, 2020 Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg... GMP Deviations: Potential to contain 1-propanol. Class II Nanomateriales Sa De Cv
Aug 18, 2020 Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33... GMP Deviations: Potential to contain 1-propanol. Class II Nanomateriales Sa De Cv
Aug 18, 2020 Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufact... cGMP Deviations Class II GRUPO YACANA MEXICO SAS DE CV

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.