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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 a) 33... | 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 25 kg... | 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 | 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 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 | 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 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 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 | 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 | 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 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 | 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 | 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 | 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 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 | 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 | 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 | BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 | Failed Impurity /Degradation Specifications | Class II | Par Pharmaceutical Inc. |
| Aug 7, 2020 | UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged... | Subpotent drug | Class II | Santa Cruz Biotechnology, Inc |
| 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 | 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 6, 2020 | Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy ... | Lack of Assurance of Sterility | Class II | Family Pharmacy of Statesville |
| Aug 6, 2020 | Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 m... | Lack of Assurance of Sterility | Class II | Family Pharmacy of Statesville |
| Aug 6, 2020 | Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy... | Lack of Assurance of Sterility | Class II | Family Pharmacy of Statesville |
| Aug 6, 2020 | Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmac... | Lack of Assurance of Sterility | Class II | Family Pharmacy of Statesville |
| Aug 6, 2020 | Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... | 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 |
| 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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. |
| 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 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... | Subpotent drug: Out of specification for assay at the 15-month test interval. | Class II | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Aug 3, 2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... | Class III | Ultra Seal Corporation |
| Aug 3, 2020 | Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol ... | Labeling Not Elsewhere Classified: Product labeled to contain methanol. | Class II | Leiper's Fork Distillery |
| Aug 3, 2020 | Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... | Class III | Ultra Seal Corporation |
| Jul 31, 2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F... | Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ... | Class III | The Mentholatum Company |
| 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. |
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.