Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 3, 2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... | Class III | Apotex Corp. |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25... | Mislabeling: The active ingredient list on the label does not match the product's actual ingredie... | Class III | Eco Lips, Inc |
| Apr 27, 2022 | Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint ... | Subpotent drug: Low OOS for menthol content at the three month room temperature. | Class III | Bestco LLC |
| Apr 15, 2022 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... | Failed viscosity specification - product was below specificcation | Class III | Akorn, Inc. |
| Apr 14, 2022 | Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content | Class III | Monarch PCM, LLC |
| Apr 13, 2022 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... | cGMP deviations: Temperature abuse | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 12, 2022 | Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... | Subpotent Drug: Out of specification for assay. | Class III | American Health Packaging |
| Apr 5, 2022 | Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... | Subpotent Drug: Out of Specification results for Assay | Class III | Aurobindo Pharma USA Inc. |
| Apr 1, 2022 | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... | Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... | Class III | The Ritedose Corporation |
| Apr 1, 2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 1, 2022 | Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... | Subpotent | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 29, 2022 | Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, ... | Incorrect/Undeclared Excipient: Product contains alcohol | Class III | AptaPharma Inc. |
| Mar 18, 2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... | Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability stud... | Class III | Advanced Accelerator Applications USA, Inc. |
| Mar 16, 2022 | Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 10, 2022 | Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... | FAILED CONTENT UNIFORMITY SPECIFICATIONS | Class III | Macleods Pharma Usa Inc |
| Mar 8, 2022 | Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... | Sub Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... | Sub Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... | Super Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... | Sub Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Feb 25, 2022 | Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... | Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Feb 17, 2022 | Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... | Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 14, 2022 | Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... | Subpotent drug | Class III | BayCare Integrated Service Center, LLC /dba Bay... |
| Jan 19, 2022 | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 10, 2022 | Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 4, 2022 | QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... | 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. |
| Jan 4, 2022 | Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... | 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 | Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... | 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 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... | 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 | 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 | 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 | 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 | 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 |
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.