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Browse Drug Recalls

73 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 73 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 73 FDA drug recalls.

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DateProductReasonClassFirm
Oct 19, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... Defective Container Class II Teligent Pharma, Inc.
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... Class II Teligent Pharma, Inc.
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... Class II Teligent Pharma, Inc.
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... Superpotent Drug Class I Teligent Pharma, Inc.
Aug 23, 2021 Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g... Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ing... Class II Teligent Pharma, Inc.
Aug 3, 2021 Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... Superpotent Drug Class I Teligent Pharma, Inc.
Jul 29, 2021 Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma,... Defective container: possibility for lack of seal integrity. Class II Teligent Pharma, Inc.
Jul 29, 2021 Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a lam... Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determi... Class III Teligent Pharma, Inc.
Jul 19, 2021 Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma... Correct Labeled Product Mispack Class II Teligent Pharma, Inc.
Jul 19, 2021 Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent P... Correct Labeled Product Mispack Class II Teligent Pharma, Inc.
Jun 22, 2021 Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., ... Failed Impurities/Degradation Specifications Class III Teligent Pharma, Inc.
Jun 22, 2021 Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(N... Failed Impurities/Degradation Specifications Class III Teligent Pharma, Inc.
May 14, 2021 Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-... Presence of Foreign Substance: Foreign particles observed during routine stability testing. Class II Teligent Pharma, Inc.
Apr 9, 2021 Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pha... Failed Impurities/Degradation Specifications: Class II Teligent Pharma, Inc.
Mar 29, 2021 Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... Failed Stability Specifications: product did not meet viscosity results. Class III Teligent Pharma, Inc.
Feb 2, 2021 Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 gr... Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class III Teligent Pharma, Inc.
Feb 2, 2021 Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr... Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class III Teligent Pharma, Inc.
Feb 2, 2021 Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 g... Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class III Teligent Pharma, Inc.
Nov 5, 2020 Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent... Superpotent and Subpotent; low and high assay results Class III Teligent Pharma, Inc.
Nov 3, 2020 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only,... Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results. Class III Teligent Pharma, Inc.
Sep 28, 2020 Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-1... Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. Class III Teligent Pharma, Inc.
May 20, 2019 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC ... Failed Impurities/Degradation Specifications Class III Teligent Pharma, Inc.
Apr 7, 2017 Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, In... Superpotent Drug Class III Teligent, 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.