Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2018 | Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical C... | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine... | Class II | Sichuan Friendly Pharmaceutical Co.,Ltd. |
| Aug 21, 2018 | Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 20, 2018 | Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, H... | Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tabl... | Class II | Hetero Labs Limited Unit V |
| Aug 20, 2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... | Class II | RemedyRepack Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 15, 2018 | Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... | Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ... | Class I | Hetero Labs Limited Unit V |
| Aug 15, 2018 | Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Preferred Pharmaceuticals, Inc |
| Aug 14, 2018 | Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) I... | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | Class III | United Therapeutics Corp. |
| Aug 14, 2018 | Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... | Supterpotent Drug | Class II | Mckesson Corporation |
| Aug 14, 2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... | Failed Impurities/Degradation Specifications; out of specification results for related compound p... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Aug 14, 2018 | Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used dur... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 13, 2018 | Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Livin... | Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of... | Class I | Living Well Remedies, LLC |
| Aug 13, 2018 | Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: ... | Presence of Foreign Substance: Product complaint was received of metal contaminant observed in on... | Class II | Lupin Pharmaceuticals Inc. |
| Aug 10, 2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville... | Incorrect Product Formulation | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 10, 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 3260... | Lack of Process Controls | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 10, 2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tro... | Lack of Process Controls | Class II | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Aug 9, 2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90... | Defective Container: Customer complaints of punctures in the bottle. | Class III | Orexigen Therapeutics, Inc. |
| Aug 8, 2018 | Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle... | Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-... | Class III | Akorn, Inc. |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 7, 2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 5... | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged l... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals 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.