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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jun 23, 2015 CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS R... Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Class III Abrams Royal Pharmacy II, LLC
Dec 19, 2013 All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc.... Lack of Assurance of Sterility Class II Abrams Royal Pharamacy
Dec 19, 2013 MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis Class I Abrams Royal Pharamacy
May 31, 2013 Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, ... Non-Sterility: The firm's contract testing laboratory found sterility failures. Class I Abrams Royal Pharmacy
May 13, 2013 Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as... Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Class I Abrams Royal Pharmacy
Apr 19, 2013 Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluro... Non-Sterility Class I Abrams Royal 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.