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Browse Drug Recalls

27 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 27 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 27 FDA drug recalls.

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DateProductReasonClassFirm
Jun 16, 2025 Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded p... Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot n... Class III Qualgen, LLC
Oct 17, 2018 Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-11... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-18... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-1... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 c... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-0... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06)... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-... Lack of Assurance of Sterility Class II Qualgen, LLC
Oct 17, 2018 Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (ND... Lack of Assurance of Sterility Class II Qualgen, LLC
Jun 8, 2018 TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Q... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 8, 2018 ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualge... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Apr 19, 2017 Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count,... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count an... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Oct 9, 2015 Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 2... Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due ... Class II Qualgen
Oct 9, 2015 Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg... Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due ... Class II Qualgen

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.