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 |
|---|---|---|---|---|
| Feb 10, 2022 | RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton,... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... | Class I | Positive Health |
| Feb 9, 2022 | Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Cap... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... | Class I | Walmart Stores |
| Feb 9, 2022 | Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE ... | Failed Impurities/Degradation Specifications: Out of specification results for related substances. | Class II | Lannett Company, Inc. |
| Feb 8, 2022 | THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters ... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... | Class I | Your Favorite Shop |
| Feb 8, 2022 | MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLD... | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... | Class I | ABC Sales 1 Inc |
| Feb 8, 2022 | MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08... | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... | Class I | ABC Sales 1 Inc |
| Feb 8, 2022 | RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN ... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tad... | Class I | Celebrate Today |
| Feb 7, 2022 | Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by:... | Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Relat... | Class II | Teligent Pharma, Inc. |
| Feb 7, 2022 | 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 M... | Labeling - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Feb 7, 2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by:... | Labeling - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Feb 7, 2022 | Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: ... | Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubrican... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 7, 2022 | Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx ... | Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufa... | Class II | RISING PHARMACEUTICALS |
| Feb 4, 2022 | MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters pa... | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingr... | Class I | Junp Hydration LLC |
| 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 | PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton togethe... | Non-sterility | Class I | CooperSurgical, 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. |
| 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 3, 2022 | Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose ... | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... | Class I | STAQ Pharma, Inc. |
| Feb 3, 2022 | HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Do... | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorre... | Class I | STAQ Pharma, Inc. |
| Jan 28, 2022 | HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per... | Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed... | Class I | Esupplementsales, LLC |
| Jan 28, 2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles p... | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... | Class II | AMS Packaging Inc |
| Jan 28, 2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle pa... | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... | Class II | AMS Packaging 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 | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... | 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 | 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 | 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 | 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 | RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... | 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 | 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 | ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, UL... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ... | Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot | Class I | AuroMedics Pharma LLC |
| Jan 26, 2022 | HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx onl... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Man... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| 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 | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... | 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 | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tab... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healt... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... | CGMP Deviations | Class II | ULTRAtab Laboratories, 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.