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Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
Mar 11, 2013 Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co.,... Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the... Class III Hi-Tech Pharmacal Co., Inc.
Dec 28, 2012 Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, M... Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for ... Class I Advance Pharmaceutical Inc
Nov 26, 2012 TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packa... Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the di... Class III Pfizer Inc.
Nov 21, 2012 Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmac... Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and descripti... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 23, 2012 ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxida... Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stabl... Class III Estee Lauder Inc
Jul 18, 2012 Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & C... Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary... Class III Fougera Pharmaceuticals Inc.
Jul 18, 2012 Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Ace... Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free ... Class II LNK International, Inc.
Jun 20, 2012 Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (3... Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the ... Class II Medtech Products, Inc.
Jun 14, 2012 Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.... Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... Class II Dukal Corp.
Jun 14, 2012 ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (eff... Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... Class II Dukal Corp.
Jun 7, 2012 Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only.... Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di... Class III Fougera Pharmaceuticals, Inc.
May 25, 2012 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone ... Class III Mallinckrodt Inc.
May 25, 2012 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... CGMP Deviations: This product is being recalled because expired flavoring was used in the manufac... Class II Mallinckrodt Inc.
Apr 24, 2012 Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and I... Presence of Particulate Matter Class II Luitpold Pharmaceuticals, Inc.
Feb 23, 2012 Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: Ameri... Marketed Without an Approved ANDA/NDA: presence of sildenafil Class I www.vitaminbestbuy.com
Feb 23, 2012 Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American ... Marketed Without an Approved ANDA/NDA: presence of sildenafil. Class I www.vitaminbestbuy.com
Feb 23, 2012 Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipo... Marketed Without an Approved ANDA/NDA: presence of sibutramine Class I www.vitaminbestbuy.com
Mar 15, 2011 CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL... Presence of Particulate Matter: In the course of inspecting retention samples visual particles w... Class II Luitpold Pharmaceuticals, Inc.

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.