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
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, 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, 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, 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 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) 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) 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) 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 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) 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) 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 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 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 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 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 19, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx ... CGMP Deviations Class II BAYSHORE PHARMACEUTICALS
Aug 19, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx O... 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
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 17, 2020 Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural... Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be cont... Class I Maison Terre, LLC
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 14, 2020 Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. Class II Hikma Pharmaceuticals USA Inc.
Aug 14, 2020 SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: ... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Boli... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Al... Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the la... Class I Volu-Sol, Inc.
Aug 14, 2020 Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packag... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-... Class I Grupo Asimex de Mexico SA de CV
Aug 14, 2020 SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG2... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 10, 2020 Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength... Presence of Foreign Substance: product complaints were received by the firm for the presence of m... Class II Aurobindo Pharma USA Inc.
Aug 10, 2020 Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannet... Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contai... Class II Lannett Company, Inc.
Aug 10, 2020 Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... Failed Stability Specifications: Out of Specification result for enzyme activity levels noted dur... Class II Sanofi-Aventis U.S. LLC
Aug 10, 2020 BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 Failed Impurity /Degradation Specifications Class II Par Pharmaceutical Inc.
Aug 7, 2020 Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in ... Labeling Not Elsewhere Classified: Product labeled to contain methanol Class II Open Book Extracts
Aug 7, 2020 Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-... Labeling Not Elsewhere Classified: Product labeled to contain methanol Class II Open Book Extracts
Aug 7, 2020 UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged... Subpotent drug Class II Santa Cruz Biotechnology, Inc
Aug 6, 2020 Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesvill... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufacture... Failed Tablet/Capsule Specification; complaint of bulging tablet Class II Hetero Labs Limited (Unit V)
Aug 6, 2020 Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kill... Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for e... Class I Incredible Products, SA de CV
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Fa... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy o... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of S... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharm... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville

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.