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.

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DateProductReasonClassFirm
Jul 11, 2019 CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, In... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. ... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Man... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. ... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distribut... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspe... Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the a... Class II Tris Pharma Inc.
Jul 11, 2019 Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsbu... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CR... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Adult Glycerin Suppositories, Package Size 50-count suppositories, Distribute... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 Adult Glycerin Suppositories, Package Size 100-count suppositories, Distribut... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jul 11, 2019 CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Ta... CGMP Deviations: Out of Specification results for either total microbial count or total organic c... Class II US Pharmaceuticals Inc.
Jun 25, 2019 Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U... Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da... Class III AAA Pharmaceutical, Inc.
Jun 20, 2019 Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, US... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tab... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Ma... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tabl... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for:... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 7, 2019 Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syri... Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the... Class I PharMEDium Services, LLC
Jun 6, 2019 LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Jun 6, 2019 LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Relea... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Releas... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extende... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Exten... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 3, 2019 Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (... Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. Class II Glenmark Pharmaceuticals Inc., USA
May 21, 2019 PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 21, 2019 AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 20, 2019 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC ... Failed Impurities/Degradation Specifications Class III Teligent Pharma, Inc.
May 13, 2019 Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactur... Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo... Class II MALLINCKRODT PHARMACEUTICALS
May 13, 2019 Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufacture... Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo... Class II MALLINCKRODT PHARMACEUTICALS
May 11, 2019 Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by:... Cross Contamination with Other Products: product is being recalled due to possible cross-contamin... Class I Novartis Pharmaceuticals Corp.
May 6, 2019 Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Ma... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufa... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufac... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: C... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufac... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by:... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA 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.