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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%... | 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 | 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 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 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 |
| 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. |
| Jul 30, 2020 | NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcoho... | 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. |
| Jul 30, 2020 | Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol ... | 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. |
| Jul 30, 2020 | NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ... | 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. |
| Jul 30, 2020 | Assured Instant Hand Sanitizer Vitamin E and Aloe (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. |
| Jul 30, 2020 | Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab I... | Discoloration and Presence of Foreign Substance | Class II | Ecolab Inc |
| Jul 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| Jul 27, 2020 | Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... | CGMP Deviations: products were recalled because they were manufactured in the same facility as th... | Class II | Broncolin, S.A. de C.V. |
| Jul 27, 2020 | HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.... | cGMP deviations | Class II | RESOURCE RECOVERY & TRADING LLC |
| Jul 27, 2020 | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (20... | cGMP deviations | Class II | RESOURCE RECOVERY & TRADING LLC |
| Jul 27, 2020 | Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-041... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Al... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & C... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
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.