Browse Drug Recalls
136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 136 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 136 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 10, 2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... | CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Preferred Pharmaceuticals, Inc |
| May 21, 2019 | Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough sup... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, US... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, US... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fa... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydra... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| Apr 24, 2019 | DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-un... | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Class II | MAJOR PHARMACEUTICALS |
| Jan 10, 2019 | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | MAJOR PHARMACEUTICALS |
| Jul 30, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do... | Failed Dissolution Specifications | Class II | MAJOR PHARMACEUTICALS |
| Jul 18, 2018 | Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pha... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | MAJOR PHARMACEUTICALS |
| Jul 18, 2018 | Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Phar... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | MAJOR PHARMACEUTICALS |
| Jun 26, 2018 | Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... | Class III | MAJOR PHARMACEUTICALS |
| Jun 26, 2018 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... | Class III | MAJOR PHARMACEUTICALS |
| Sep 26, 2017 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... | Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. | Class II | The Harvard Drug Group |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Aug 16, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 2, 2017 | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Jan 5, 2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jan 5, 2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Dec 27, 2016 | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ... | Superpotent Drug; out of specification results for assay (manufacturer) | Class III | The Harvard Drug Group |
| Aug 8, 2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Jul 28, 2015 | Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets ... | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Class III | Ohm Laboratories, Inc. |
| Jun 10, 2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manuf... | Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 ... | Class II | The Harvard Drug Group, LLC |
| Jul 16, 2014 | Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Ch... | Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspens... | Class II | Bio-pharm, Inc. |
| Apr 10, 2014 | Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube p... | Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... | Class II | Bausch & Lomb, Inc. |
| Apr 9, 2014 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... | Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... | Class II | Legacy Pharmaceutical Packaging |
| Mar 27, 2013 | Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceu... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 | Class III | Legacy Pharmaceutical Packaging LLC |
| Sep 20, 2012 | Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manuf... | Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacycl... | Class III | Sandoz Incorporated |
| Aug 17, 2012 | Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by... | Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide... | Class III | Axcentria Pharmaceuticals LLC |
| Jul 12, 2012 | Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 m... | Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packagi... | Class III | Axcentria Pharmaceuticals LLC |
| Sep 27, 2011 | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta... | Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calc... | Class II | Shamrock Medical Solutions Group 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.