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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Mar 4, 2024 Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... Presence of Particulate Matter. Class I Par Sterile Products LLC
Jan 11, 2024 Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... Class II Par Sterile Products LLC
Nov 9, 2021 Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use,... Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during ... Class II PAR Sterile Products LLC
Apr 28, 2017 Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-... Crystallization: due to the presence of white, crystalline particulates, adhered to the side and ... Class II PAR Sterile Products 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.