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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.