Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 (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 6, 2013 | REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple... | Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the ... | Class II | Showline Automotive Products, Inc. dba US Soaps... |
| Aug 2, 2013 | Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum S... | Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 18, 2013 | ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... | Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... | Class III | Vi-Jon, Inc. |
| Jun 20, 2013 | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infu... | Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bact... | Class II | Gilead Sciences, Inc. |
| Jun 19, 2013 | AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial,... | Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on cert... | Class II | Astellas Pharma US Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| May 16, 2013 | West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... | Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets containe... | Class II | West-Ward Pharmaceutical Corp. |
| May 8, 2013 | Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML | Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopano... | Class II | Fusion Pharmaceuticals, LLC |
| Apr 18, 2013 | Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for S... | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 ... | Class II | Sandoz Incorporated |
| Apr 5, 2013 | Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05)... | Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off... | Class III | Glenmark Generics Inc., USA |
| Apr 5, 2013 | Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90... | Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to ... | Class III | Glenmark Generics Inc., USA |
| Apr 5, 2013 | Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx... | Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off ... | Class III | Glenmark Generics Inc., USA |
| 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. |
| 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 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 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 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 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 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 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 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 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 200 mcg, packaged in a) 100-count... | Chemical contamination: emission of strong odor after package was opened. | Class II | Pfizer Inc. |
| Mar 16, 2013 | "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simeth... | Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count ... | Class II | Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals |
| Mar 14, 2013 | Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infu... | Non-Sterility; mold contamination | Class I | Med Prep Consulting, Inc. |
| Mar 14, 2013 | All Compounded Products, packaged in plastic infusion bags, devices, syringes... | Lack of Assurance of Sterility; potential for mold contamination | Class II | Med Prep Consulting, Inc. |
| Feb 15, 2013 | Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) ... | Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin ... | Class II | Dr Reddys Laboratories Tennessee LLC |
| Feb 15, 2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg,... | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ... | Class III | Warner Chilcott Company LLC |
| Feb 15, 2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg... | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ... | Class III | Warner Chilcott Company LLC |
| Feb 15, 2013 | Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 ... | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ... | Class III | Warner Chilcott Company LLC |
| Feb 13, 2013 | Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per... | Chemical Contamination: The recall has been initiated based on multiple complaints received from ... | Class III | Glenmark Generics Inc., USA |
| Jan 23, 2013 | Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz)... | Cross Contamination with Other Products: Product was mixed with another type of mouth wash. | Class III | Procter & Gamble Hair Care Llc |
| Jan 17, 2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... | Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminat... | Class II | Humco Holding Group, Inc |
| Dec 28, 2012 | HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride ... | Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. | Class II | Hillyard GMP |
| Dec 21, 2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... | Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... | Class II | Lee Pharmaceuticals, Inc |
| Dec 18, 2012 | Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl... | Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia ce... | Class I | Matrixx Initiatives Inc |
| Nov 29, 2012 | NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for ... | Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological sp... | Class II | Mariposa Labs, LLC |
| Oct 19, 2012 | Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg,... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, ... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, in... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson 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.