Browse Drug Recalls
2,021 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,021 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 2,021 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 1, 2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... | Labeling: Incorrect or Missing Package Insert | Class III | Sanofi-Aventis U.S. LLC |
| Aug 30, 2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... | Class III | Actavis Laboratories, FL, Inc. |
| Aug 19, 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister... | Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl... | Class I | Impax Laboratories, Inc. |
| Aug 18, 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re... | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of... | Class III | West-Ward Pharmaceuticals Corp. |
| Aug 4, 2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Genzyme Corporation / Genzyme Biosurgery |
| Aug 3, 2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa... | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydram... | Class III | Reckitt Benckiser LLC |
| Jul 29, 2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jun 28, 2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... | Class III | Golden State Medical Supply Inc. |
| Jun 13, 2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... | Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Jun 10, 2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... | Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy... | Class III | Valeant Pharmaceuticals North America LLC |
| May 30, 2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... | Class III | Prinston Pharmaceutical Inc |
| May 25, 2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... | Labeling: Incorrect or Missing Package Insert | Class III | Sandoz Inc |
| May 23, 2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... | Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 19, 2016 | Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Markete... | Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. | Class III | Galderma Laboratories, L.P. |
| May 16, 2016 | Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMED... | Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label s... | Class II | Pharmedium Services, LLC |
| May 10, 2016 | Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (1... | Labeling; Product Contains Undeclared API (Oxybenzone) | Class II | Bayer Health Care LLC |
| Apr 29, 2016 | BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifes... | Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. | Class I | Making It a Lifestyle |
| Apr 27, 2016 | Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Ge... | Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL ... | Class III | Genzyme Corporation / Genzyme Biosurgery |
| Apr 22, 2016 | Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bot... | Labeling: Not elsewhere classified - count on the label was incorrect. | Class III | A-S Medication Solutions LLC. |
| Apr 20, 2016 | FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The People... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeli... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individu... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFA... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, r... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within ... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count b... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a ... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, U... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peopl... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, ... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 20, 2016 | SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peopl... | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... | Class II | Murray International Trading Co., Inc. |
| Apr 12, 2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... | Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. | Class III | Mckesson Packaging Services |
| Apr 7, 2016 | Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ... | Presence of Particulate Matter | Class II | Akorn, Inc. |
| Apr 5, 2016 | Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... | Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres... | Class II | Fresenius Kabi USA, LLC |
| Mar 31, 2016 | Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Amerisource Health Services |
| Mar 31, 2016 | Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Amerisource Health Services |
| Mar 30, 2016 | PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... | Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case... | Class I | QuVa Pharma, Inc. |
| Mar 25, 2016 | CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... | Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine | Class I | Reliable Rexall-A Compounding Pharmacy |
| Mar 25, 2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle... | Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta... | Class III | Bryant Ranch Prepack Inc. |
| Mar 24, 2016 | Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for:... | Labeling: Incorrect or Missing Lot and/or Expiration Date | Class III | Lupin Limited |
| Mar 17, 2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distribu... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Impax Laboratories, Inc. |
| Mar 17, 2016 | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distribu... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Impax Laboratories, Inc. |
| Mar 15, 2016 | Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiratio... | Class III | Hospira Inc. |
| Mar 14, 2016 | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 14, 2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL... | Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the... | Class II | Meditech Laboratories, Inc |
| Mar 11, 2016 | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J... | Labeling: Label Error on Declared Strength | Class III | Jubilant Draximage Inc |
| Feb 12, 2016 | Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Do... | Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with a... | Class III | Apace KY LLC |
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.