Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2019 | Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC:... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/... | 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 or Rectal Administration, Rx Onl... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rect... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol fre... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic ... | 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 |
| May 21, 2019 | Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... | 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 23155-317... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx On... | 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 | Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551... | 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 | 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 21, 2019 | Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Bisacodyl Suppositories, Brite Stock, Reese. | 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 | Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. o... | 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 | Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) ... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle... | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Torrent Pharma Inc |
| May 21, 2019 | Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol ... | 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 | 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 | 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 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 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 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 | 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 |
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.