Browse Drug Recalls

1,056 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,056 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 1,056 FDA drug recalls.

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DateProductReasonClassFirm
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 24, 2025 Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... Failed stability specifications: Out of specification for hardness test Class II Cipla USA, Inc.
Oct 24, 2025 Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... Failed stability specifications: Out of specification for hardness test Class II Cipla USA, Inc.
Oct 10, 2025 Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx on... Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... Class II The Harvard Drug Group LLC
Oct 10, 2025 Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only,... Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... Class II The Harvard Drug Group LLC
Sep 29, 2025 Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distribu... Failed dissolution specifications: Stability testing found that the lot did not meet dissolution ... Class II Acella Pharmaceuticals, LLC
Sep 26, 2025 Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL ... Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative co... Class II Dr. Reddy's Laboratories, Inc.
Sep 16, 2025 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the... Class II ACCORD HEALTHCARE, INC.
Aug 8, 2025 Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by ... Class II Glenmark Pharmaceuticals Inc., USA
Jul 24, 2025 Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... Failed Stability Specifications: Out of specification results was observed in Induction Port duri... Class III Cipla USA, Inc.
Jul 9, 2025 Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... Sub-Potent Drug: Subpotent assay results during stability testing. Class II Imprimis NJOF, LLC
Jul 9, 2025 Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... Sub-Potent Drug: Subpotent assay results during stability testing. Class III Imprimis NJOF, LLC
Jun 24, 2025 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... Class II Granules Pharmaceuticals Inc.
Jun 16, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 29, 2025 Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL ... Failed Stability Specifications: Out of specification results for the Color Absorbance test duri... Class II Eugia US LLC
May 23, 2025 Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx... Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... Class II Ascend Laboratories, LLC
May 23, 2025 Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx... Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... Class II Ascend Laboratories, LLC
May 19, 2025 Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances t... Class III Glenmark Pharmaceuticals Inc., USA
May 13, 2025 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count S... Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... Class II Zydus Pharmaceuticals (USA) Inc
May 13, 2025 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count s... Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... Class II Zydus Pharmaceuticals (USA) Inc
Apr 21, 2025 Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 21, 2025 Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-d... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 15, 2025 HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette,... Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was ... Class III OurPharma LLC
Apr 10, 2025 clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Ma... Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... Class II Lupin Pharmaceuticals Inc.
Mar 4, 2025 Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... Failed Dissolution Specifications: Out of specification results obtained during routine stability... Class III The Harvard Drug Group LLC dba Major Pharmaceut...
Feb 27, 2025 Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... Stability data does not support expiry: the products have the potential to be out of specificatio... Class II Amgen, Inc.
Feb 27, 2025 Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... Stability data does not support expiry: the products have the potential to be out of specificatio... Class II Amgen, Inc.
Feb 24, 2025 Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... Class III Imprimis NJOF, LLC
Feb 4, 2025 Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, ... Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stabili... Class II AvKARE
Jan 21, 2025 Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blist... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 21, 2025 Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blist... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 21, 2025 Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 bli... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 10, 2025 Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... Failed Stability Specifications - 12-month stability test result for one of the known peptides is... Class II Teva Pharmaceuticals USA, Inc
Jan 8, 2025 babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide ... Failed stability specifications: during routine stability monitoring quality concerns were identi... Class II Johnson, S C and Son, Inc
Dec 23, 2024 Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... Class II Viatris Inc
Dec 23, 2024 Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... Class II Viatris Inc
Dec 20, 2024 Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug s... Class II Lupin Pharmaceuticals Inc.
Dec 18, 2024 Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... Failed Dissolution Specifications: Out of specification observed during the accelerated stability... Class II Granules Pharmaceuticals Inc.
Nov 22, 2024 Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL ... Failed Stability Specifications Class II Jubilant Draximage Inc., dba Jubilant Radiopharma
Nov 5, 2024 Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distribu... Failed Impurities/Degradation Specifications; during routine stability testing for impurities. Class III The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 21, 2024 Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Ath... Superpotent Drug: Stability failure for assay at 6 months test time-point. Class II BLI International, Inc.
Oct 11, 2024 Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Man... Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity... Class III Padagis US LLC
Aug 21, 2024 Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month lon... Class II Lupin Pharmaceuticals Inc.
Aug 9, 2024 Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 80... Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-mo... Class II Direct Rx
Aug 8, 2024 Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... Failed Impurities/Degradation Specifications - at 18-month Stability testing Class II Preferred Pharmaceuticals, Inc.
Aug 7, 2024 Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... Class III Taro Pharmaceuticals U.S.A., 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.