Browse Drug Recalls
1,018 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,018 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 1,018 FDA drug recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 6, 2013 | Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottl... | Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact ... | Class I | Altaire Pharmaceuticals, Inc. |
| Sep 5, 2013 | Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL s... | Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility ass... | Class II | Fallon Wellness Pharmacy Llc |
| Sep 4, 2013 | GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-... | Subpotent; phenylephrine HCl | Class III | Hi-Tech Pharmacal Co., Inc. |
| Sep 4, 2013 | Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, ... | Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... | Class II | Pfizer Us Pharmaceutical Group |
| Aug 17, 2013 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne... | Failed dissolution specifications; 18 month CRT | Class II | Amneal Pharmaceuticals of New York, LLC. |
| Aug 8, 2013 | Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-N... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bo... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physicia... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 ... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 table... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 5, 2013 | Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powde... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desme... | Class I | Bethel Nutritional Consulting, Inc |
| Aug 5, 2013 | Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear s... | Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-d... | Class I | Bethel Nutritional Consulting, Inc |
| Jul 31, 2013 | Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Ch... | Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this produ... | Class I | Healthy Life Chemistry Inc dba Purity First |
| Jul 31, 2013 | B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, ... | Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclare... | Class I | Healthy Life Chemistry Inc dba Purity First |
| Jul 25, 2013 | Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... | Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab... | Class III | Hi-Tech Pharmacal Co., Inc. |
| Jul 22, 2013 | METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic ... | Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid an... | Class I | Mira Health Products Ltd. |
| Jul 22, 2013 | B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count ... | Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine whic... | Class I | Mira Health Products Ltd. |
| Jul 22, 2013 | Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle ... | Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17... | Class I | Mira Health Products Ltd. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 17, 2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... | Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... | Class I | Advance Pharmaceutical Inc |
| Jun 11, 2013 | Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. ... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibut... | Class I | Bethel Nutritional Consulting, Inc |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.... | Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogen... | Class III | Pfizer Inc. |
| May 31, 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.... | Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxy... | Class III | Pfizer Inc. |
| Apr 30, 2013 | Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold l... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | American Lifestyle.Com |
| Apr 30, 2013 | Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box,... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | American Lifestyle.Com |
| Apr 30, 2013 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... | Subpotent; 24 month stability test station | Class III | Hi-Tech Pharmacal Co., Inc. |
| Apr 8, 2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 m... | Subpotent; Cetylpyridinum Chloride | Class III | Hi-Tech Pharmacal Co., Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-coun... | Chemical contamination: emission of strong odor after package was opened | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count ... | Chemical contamination: emission of strong odor after package was opened.. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 28, 2013 | Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer 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.