DrugJul 26, 2023
SterRx Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL recall — FDA D-0934-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedSterRx, LLC
10,685drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 59
10,685 detailed records are currently available in this category.
DrugJul 26, 2023
New England Life Care, Inc. dba Advanced PHENYLephrine HCl 10mg added to 0.9% Sodium recall — FDA D-0927-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class IIFDA: TerminatedNew England Life Care, Inc. dba Advanced Compounding…
DrugJul 19, 2023
EQUATE EYE DROPS DRY EYE RELIEF Dry Eye Relief Lubricant Eye Drops recall — FDA D-0898-2023
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class IIFDA: OngoingK.C. Pharmaceuticals, Inc.
DrugJul 19, 2023
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles recall — FDA D-0913-2023
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class IIFDA: TerminatedTeva Pharmaceuticals USA Inc.
DrugJul 19, 2023
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle recall — FDA D-0914-2023
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJul 19, 2023
Global Pharma Healthcare Private Artificial Tears recall — FDA D-0919-2023
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class IFDA: OngoingGlobal Pharma Healthcare Private Limited
DrugJul 19, 2023
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles recall — FDA D-0899-2023
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 19, 2023
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials recall — FDA D-0918-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugJul 19, 2023
Global Pharma Healthcare Private Delsam Pharma's ARTIFICIAL TEARS recall — FDA D-0921-2023
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class IFDA: OngoingGlobal Pharma Healthcare Private Limited
DrugJul 19, 2023
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g recall — FDA D-0938-2023
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class IFDA: TerminatedCipla USA, Inc.
DrugJul 19, 2023
Global Pharma Healthcare Private Artificial Tears recall — FDA D-0920-2023
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be…
Class IIFDA: OngoingGlobal Pharma Healthcare Private Limited
DrugJul 19, 2023
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials recall — FDA D-0917-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugJul 19, 2023
Global Pharma Healthcare Private Delsam Pharma's ARTIFICIAL TEARS recall — FDA D-0922-2023
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be…
Class IIFDA: OngoingGlobal Pharma Healthcare Private Limited
DrugJul 19, 2023
SUNMARK EYE DROPS ORIGINAL FORMULA Original Eye Drops recall — FDA D-0897-2023
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class IIFDA: OngoingK.C. Pharmaceuticals, Inc.
DrugJul 19, 2023
Tenn South Distillery LLC dba Big Machine Big Machine Distillery Hand Sanitizer Non-Sterile recall — FDA D-0915-2023
CGMP Deviation: impurities exceed allowable limits.
Class IIFDA: OngoingTenn South Distillery LLC dba Big Machine Distillery
DrugJul 12, 2023
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle recall — FDA D-0895-2023
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class IIFDA: TerminatedStrides Pharma Inc.
DrugJul 12, 2023
Tizanidine Hydrochloride Tablet 4mg recall — FDA D-0894-2023
Failed Stability Specifications
Class IIFDA: OngoingPreferred Pharmaceuticals, Inc.
DrugJul 12, 2023
Tizanidine Tablets, USP, 4 mg, 100 Tablets recall — FDA D-0892-2023
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class IIFDA: TerminatedAmerisource Health Services LLC
DrugJul 5, 2023
The Harvard Drug Group Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count recall — FDA D-0878-2023
Packaging defect: blister packaging inadequately sealed.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugJun 28, 2023
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules recall — FDA D-0893-2023
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5…
Class IFDA: TerminatedThe Harvard Drug Group LLC dba Major Pharmaceuticals…
DrugJun 21, 2023
Jarman's Midwest Cleaning Systems Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand recall — FDA D-0872-2023
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Class IIFDA: TerminatedJarman's Midwest Cleaning Systems, Inc.
DrugJun 21, 2023
Jarman's Midwest Cleaning Systems SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND recall — FDA D-0874-2023
Chemical Contamination: FDA testing found Presence of methanol
Class IFDA: TerminatedJarman's Midwest Cleaning Systems, Inc.
DrugJun 14, 2023
Empower Clinic Services LLC dba Empower Pharmacy ASCORBIC ACID PRESERVED INJECTION SOLUTION recall — FDA D-0865-2023
Mislabeling: preservative free product labeled as preserved.
Class IIFDA: CompletedEmpower Clinic Services LLC dba Empower Pharmacy
DrugJun 14, 2023
Viatris Levsin injection recall — FDA D-0866-2023
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
Class IIFDA: TerminatedViatris Inc.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.