Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant,... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl... | 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 | Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administrati... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589... | 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 | Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin &... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 F... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma 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 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blis... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per bliste... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| 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 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per bliste... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only,... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| 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 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 10, 2019 | QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz... | Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material. | Class III | Ecolab Inc |
| May 9, 2019 | Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count... | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | Class II | American Health Packaging |
| May 9, 2019 | Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Onl... | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | Class II | American Health Packaging |
| May 6, 2019 | The Beast, The Beast can be taken under the situation of Heart disease and ev... | Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discove... | Class I | Stiff Boy LLC |
| 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 |
| 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 | 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 | 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 | 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 | Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Ger... | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Class II | Geritrex, LLC |
| 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 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 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 | 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 | 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 | Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceutica... | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Class II | Geritrex, LLC |
| 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 | 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 | 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 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 3, 2019 | Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured b... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Heritage Pharmaceuticals, Inc. |
| May 3, 2019 | Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufa... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Heritage Pharmaceuticals, Inc. |
| May 3, 2019 | Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Ma... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Heritage Pharmaceuticals, Inc. |
| May 3, 2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manuf... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Heritage Pharmaceuticals, Inc. |
| May 3, 2019 | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA S... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| May 3, 2019 | Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured b... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Heritage Pharmaceuticals, Inc. |
| May 2, 2019 | DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 P... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg ... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fe... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, 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.