Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

Clear
DateProductReasonClassFirm
Mar 3, 2026 Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... Class II Rising Pharma Holding, Inc.
Feb 18, 2026 Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 18, 2026 MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal S... Stability Data Does Not Support Expiry Date. Class II HTO Nevada Inc. dba Kirkman
Feb 18, 2026 MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1... Stability Data Does Not Support Expiry Date. Class II HTO Nevada Inc. dba Kirkman
Feb 18, 2026 FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz... Stability Data Does Not Support Expiry Date. Class II HTO Nevada Inc. dba Kirkman
Feb 18, 2026 Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 4, 2026 Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x... Failed Impurities/Degradation Specifications - OOS impurities result observed during long term st... Class II SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 11, 2025 Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... Class III Dr. Reddy's Laboratories, Inc.
Oct 31, 2025 Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carto... Failed Stability Specifications: Observed OOS results: eg results for colour index Class II Cipla Limited
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 30 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, 40 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, 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...

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.