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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
Apr 30, 2019 Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl... Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product Class I Par Pharmaceutical, Inc.
Sep 6, 2018 Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30... Failed impurities/degradation specifications: Finished product contain a known product impurity a... Class III Par Pharmaceutical, Inc.
Oct 5, 2016 Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx... Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the ... Class II Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablet... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, ... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol table... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Nov 24, 2014 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distr... Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydro... Class II Par Pharmaceutical 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.