Browse Drug Recalls

1,034 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,034 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 1,034 FDA drug recalls in NY.

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DateProductReasonClassFirm
May 7, 2018 Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, G... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxid... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz.... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged i... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. O... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perr... Failed Stability Specifications Class II Perrigo New York
May 7, 2018 Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Mag... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 5, 2018 Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... Failed impurities/degradation specifications: Failure to water content and impurity Class III InvaGen Pharmaceuticals, Inc.
Mar 5, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... Class III Pine Pharmaceuticals, LLC
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Jan 22, 2018 Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf... Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol Class III Ascent Pharmaceuticals, Inc.
Jan 11, 2018 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 10, 2018 Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit... CGMP deviations: Ibuprofen is being recalled in response to previous recall Class II Spirit Pharmaceuticals, LLC
Jan 9, 2018 Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Dec 21, 2017 Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Phar... Failed Content Uniformity Specifications Class III Taro Pharmaceuticals U.S.A., Inc.
Dec 15, 2017 Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distribut... Presence of particulate matter Class II Amneal Pharmaceuticals
Nov 19, 2017 Hard Times For Men capsules, packaged in a 23-count box of blister packs cont... Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredie... Class I www.blankterrmall.com
Oct 20, 2017 diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m... SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class I Pfizer Inc.
Oct 20, 2017 Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed ... SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class II Pfizer Inc.
Oct 6, 2017 No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, D... Marketed Without an Approved NDA/ANDA Class II NEW RELIANCE TRADING, INC.
Sep 25, 2017 Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100... Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... Class III Amneal Pharmaceuticals, Inc.
Sep 25, 2017 Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-c... Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... Class III Amneal Pharmaceuticals, Inc.
Sep 20, 2017 Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... Cross contamination with other products: traces of Dapsone were found in the finished product. Class III Taro Pharmaceuticals U.S.A., Inc.
Sep 14, 2017 Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien... CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha... Class II Medisca, Inc.
Sep 1, 2017 Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu... Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. Class II Pfizer Inc.
Aug 30, 2017 Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... Presence of Particulate Matter: glass particulate found in vial Class I Pfizer Inc.
Aug 22, 2017 Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 22, 2017 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer 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.