Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 19, 2020 | CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Di... | Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment. | Class II | US Pharmaceuticals Inc. |
| Nov 19, 2020 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-D... | CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product f... | Class II | Areva Pharmaceuticals Inc |
| Nov 1, 2020 | Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage X... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... | Class II | Preferred Pharmaceuticals, Inc. |
| Oct 23, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Nostrum Laboratories Inc |
| Oct 23, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottl... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Nostrum Laboratories Inc |
| Oct 21, 2020 | Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. M... | CGMP Deviations | Class II | H & H Remedies, LLC |
| Oct 21, 2020 | White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold... | CGMP Deviations | Class II | H & H Remedies, LLC |
| Oct 21, 2020 | Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 1... | CGMP Deviations | Class II | H & H Remedies, LLC |
| Oct 12, 2020 | Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Daw... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Direct Rx |
| Oct 11, 2020 | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx o... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | RemedyRepack Inc. |
| Oct 8, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (ND... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Denton Pharma, Inc. |
| Oct 8, 2020 | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottl... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Denton Pharma, Inc. |
| Oct 6, 2020 | metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Ok... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Oct 6, 2020 | metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: ... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Oct 2, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Marksans Pharma Limited |
| Oct 2, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 ... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Marksans Pharma Limited |
| 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 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 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 | 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. |
| 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, 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 | 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 | 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, 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 |
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.