Browse Drug Recalls
2,097 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,097 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 2,097 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 16, 2022 | Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufa... | Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. | Class II | Macleods Pharma Usa Inc |
| Jun 14, 2022 | Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... | Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 10, 2022 | Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmac... | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Class II | Wedgewood Village Pharmacy, LLC |
| Jun 10, 2022 | Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewo... | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Class II | Wedgewood Village Pharmacy, LLC |
| Jun 10, 2022 | Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Ph... | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Class II | Wedgewood Village Pharmacy, LLC |
| Jun 10, 2022 | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Jun 10, 2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... | Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial exc... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 10, 2022 | Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension... | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Class II | Wedgewood Village Pharmacy, LLC |
| Jun 10, 2022 | Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy... | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Class II | Wedgewood Village Pharmacy, LLC |
| Jun 10, 2022 | Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:... | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Class II | Wedgewood Village Pharmacy, LLC |
| Jun 3, 2022 | Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, ... | Failed Tablet/Capsule Specification; oversized tablet found in a bottle | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rej... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 18, 2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Li... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class III | Teva Pharmaceuticals USA Inc |
| May 11, 2022 | Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... | Class I | Teva Pharmaceuticals USA Inc |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Contai... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Con... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plas... | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... | Class II | AMS Packaging Inc |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 25, 2022 | Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manuf... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manu... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 15, 2022 | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... | cGMP Deviations | Class II | Teva Pharmaceuticals USA Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 15, 2022 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Apr 5, 2022 | Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... | Subpotent Drug: Out of Specification results for Assay | Class III | Aurobindo Pharma USA Inc. |
| Apr 1, 2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 31, 2022 | Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottl... | Presence of foreign substance: Presence of stainless steel particulates in tablets. | Class II | MERCK SHARP & DOHME CORP |
| Mar 30, 2022 | Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chloroh... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | Unilever United States Inc. |
| Mar 30, 2022 | Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chloro... | Chemical contamination: presence of benzene | Class I | Unilever United States Inc. |
| Mar 29, 2022 | IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, ... | Presence of Particulate Matter: Product was found to contain silica and iron oxide | Class I | Teva Pharmaceuticals USA Inc |
| Mar 29, 2022 | Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, ... | Incorrect/Undeclared Excipient: Product contains alcohol | Class III | AptaPharma Inc. |
| Mar 23, 2022 | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... | Failed Dissolution Specifications; during long term stability testing. | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 23, 2022 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... | Failed Dissolution Specifications; during long term stability testing. | Class II | Dr. Reddy's Laboratories, 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.