Browse Drug Recalls
1,720 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,720 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 1,720 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2022 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Dec 29, 2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... | Out-of-specification impurity test result observed at 18-month long term stability time point. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 22, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Dec 3, 2021 | CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodi... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... | Labeling: Missing Label | Class III | Akorn, Inc. |
| Dec 3, 2021 | CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluor... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neut... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... | Labeling: Missing Label | Class III | Akorn, Inc. |
| Dec 1, 2021 | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot... | Superpotent; Hydrochlorothiazide | Class III | Torrent Pharma Inc. |
| Nov 19, 2021 | Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... | Subpotent Drug | Class III | Lupin Pharmaceuticals Inc. |
| Nov 15, 2021 | Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by... | Failed Impurities/Degradation Specifications | Class III | Aurobindo Pharma USA Inc. |
| Nov 12, 2021 | Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 28, 2021 | Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... | Failed Impurities/Degradation Specifications | Class III | Teva Pharmaceuticals USA |
| Oct 25, 2021 | Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... | Discoloration | Class III | UNICHEM PHARMACEUTICALS USA INC |
| Oct 20, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Oct 18, 2021 | Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Uni... | Out-of-specification test results obtained in Organic Impurities test during analysis of controll... | Class III | MACLEODS PHARMA USA, INC |
| Oct 18, 2021 | Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2... | Out-of-specification test results obtained in Organic Impurities test during analysis of controll... | Class III | MACLEODS PHARMA USA, INC |
| Oct 18, 2021 | Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Un... | Out-of-specification test results obtained in Organic Impurities test during analysis of controll... | Class III | MACLEODS PHARMA USA, INC |
| Oct 13, 2021 | Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 12, 2021 | Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 12, 2021 | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 5, 2021 | Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... | Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... | Class III | A-S Medication Solutions LLC. |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 13, 2021 | Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for:... | Failed Impurities/Degradation Specifications; out of specification for Related Compound | Class III | Viatris |
| Sep 3, 2021 | Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, ... | Failed Impurities/Degradation Specifications | Class III | Meitheal Pharmaceuticals Inc |
| Sep 2, 2021 | CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flav... | Subpotent Drug | Class III | New Vision Pharmaceuticals LLC |
| Sep 2, 2021 | Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each... | Subpotent Drug | Class III | New Vision Pharmaceuticals LLC |
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.