Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufact... | cGMP Deviations | Class II | GRUPO YACANA MEXICO SAS 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 |
| Aug 14, 2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... | CGMP Deviations: All other lots are being recalled because they were manufactured under the same ... | Class II | Grupo Asimex de Mexico SA de CV |
| Aug 4, 2020 | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eos... | cGMP Deviations. | Class II | Eosera, Inc. |
| Aug 4, 2020 | Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (1... | cGMP Deviations. | Class II | Eosera, Inc. |
| Aug 4, 2020 | Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%... | cGMP Deviations. | Class II | Eosera, Inc. |
| Aug 4, 2020 | Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250... | CGMP Deviation: Potential contamination with undeclared methanol. | Class II | ROQUE PLAST, S.A. DE C.V. |
| Aug 4, 2020 | Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL ... | cGMP Deviations. | Class II | Eosera, Inc. |
| Jul 31, 2020 | Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged ... | cGMP deviations | Class II | Laboratorios Jaloma S.A. de C.V. |
| Jul 30, 2020 | Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
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.