Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2022 | Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... | CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... | Class II | Direct Rx |
| Mar 4, 2022 | Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... | CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... | Class II | Direct Rx |
| Mar 3, 2022 | HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... | Class II | Tennessee Technical Coatings, Corp. |
| Mar 2, 2022 | Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR... | CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ... | Class II | Golden State Medical Supply Inc. |
| Feb 22, 2022 | Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... | CGMP deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Feb 18, 2022 | All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores ... | CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. | Class II | Dollar Tree Distribution, Inc. |
| Feb 16, 2022 | Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... | cGmp Deviations | Class II | Macleods Pharma Usa Inc |
| Feb 15, 2022 | Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9... | cGMP Deviations | Class II | ANI Pharmaceuticals, Inc. |
| Feb 15, 2022 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... | cGMP deviations | Class II | Macleods Pharma Usa Inc |
| Feb 4, 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... | Class II | Professional Disposables International, Inc. |
| Feb 4, 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w... | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... | Class II | Professional Disposables International, Inc. |
| Feb 4, 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.... | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... | Class II | Professional Disposables International, Inc. |
| Jan 26, 2022 | Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amnea... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactu... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAta... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Heal... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
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.