Browse Drug Recalls
91 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 91 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 91 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: T... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| Apr 11, 2022 | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets ... | CGMP deviations: tablets cracking | Class II | Torrent Pharma Inc |
| Dec 2, 2021 | Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Dec 1, 2021 | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot... | Superpotent; Hydrochlorothiazide | Class III | Torrent Pharma Inc. |
| Mar 15, 2021 | Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured b... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Nov 25, 2020 | Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... | Failed Dissolution Specifications | Class I | Torrent Pharma Inc |
| May 11, 2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx O... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manuf... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets p... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 6, 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.