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 |
|---|---|---|---|---|
| Feb 9, 2018 | Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Fluticasone propionate USP (Micronized) for prescription compounding, package... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g (... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 585... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Itraconazole USP (Micronized) for prescription compounding, packaged in a) 1... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 2... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 7, 2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... | CGMP Deviations: not manufactured according to current good manufacturing practices. | Class III | Webrx dba RxPalace.com |
| Jan 25, 2018 | PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jan 19, 2018 | Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... | Class II | AMERICAN HEALTH PACKAGING |
| Jan 11, 2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 10, 2018 | Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit... | CGMP deviations: Ibuprofen is being recalled in response to previous recall | Class II | Spirit Pharmaceuticals, LLC |
| Jan 10, 2018 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... | Class II | Hetero Labs, Ltd. - Unit III |
| Jan 9, 2018 | Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Dec 15, 2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bo... | CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufact... | Class III | Akorn Inc |
| Nov 28, 2017 | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titani... | CGMP Deviations: products manufactured in a manner that may impact product quality that includes ... | Class II | EAI-JR286 INC |
| Nov 20, 2017 | Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: G... | CGMP Deviations: Market complaints related to "gritty texture". | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 25, 2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552... | cGMP Deviations: lack of quality assurance at the API manufacturer. | Class II | Fagron, Inc |
| Sep 27, 2017 | Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), ... | CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unk... | Class II | United Pharmacy |
| Sep 14, 2017 | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien... | CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha... | Class II | Medisca, Inc. |
| Sep 11, 2017 | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg... | CGMP Deviations | Class II | United Therapeutics Corp. |
| Sep 5, 2017 | Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Steri... | Lack of Assurance of Sterility and cGMP Deviations | Class II | Simple Diagnostics, Inc. |
| Aug 30, 2017 | Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochlori... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 30, 2017 | Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephri... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Jul 12, 2017 | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... | CGMP Deviations | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jul 12, 2017 | Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... | CGMP Deviations: Firm failed to control impurity for color change at the API stage. | Class III | Pfizer Inc. |
| Jun 6, 2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... | Class II | Bausch & Lomb, Inc. |
| Jun 1, 2017 | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Dis... | CGMP Deviations | Class II | Xttrium Laboratories Inc |
| Jun 1, 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... | Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... | Class II | American Pharmaceutical Ingredients 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.