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 |
|---|---|---|---|---|
| Mar 7, 2022 | Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-via... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tail... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Tem... | Lack of Assurance of Sterility | Class II | TMC Acquisition LLC dba Tailor Made Compounding |
| 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. |
| Mar 2, 2022 | HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 4... | Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol a... | Class II | Vi-Jon, Inc. |
| Feb 28, 2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Feb 25, 2022 | 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... | Lack of sterility assurance: leaking bags | Class II | B. Braun Medical, Inc. |
| Feb 24, 2022 | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... | Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... | Class II | The Harvard Drug Group |
| Feb 22, 2022 | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL p... | Impurity failure at 0-time of the repackaged lot. | Class II | American Health Packaging |
| 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 21, 2022 | Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only,... | Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impuritie... | Class II | Morton Grove 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 17, 2022 | Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... | Failed impurities/degradation specifications | Class II | Direct Rx |
| 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 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 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 | 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 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 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 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 | 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 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 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) 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) 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. |
| 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 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 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 | 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 | 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 | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| 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 | AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... | 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 | 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 | 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 |
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.