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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 FDA drug recalls.

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DateProductReasonClassFirm
Apr 20, 2024 Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Class I Revive Rx LLC dba Revive Rx Pharmacy
May 11, 2023 Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use O... Sub-potent Drug Class II Revive Rx LLC dba Revive Rx Pharmacy
Feb 11, 2022 HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only... Non-sterility; bacterial contamination identified as Paenibacillus lautus. Class I Revive Rx LLC dba Revive Rx Pharmacy

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.