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Browse Drug Recalls

36 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 36 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 36 FDA drug recalls.

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DateProductReasonClassFirm
May 22, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l... Class II The Harvard Drug Group
Apr 20, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... Class I C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class I C. O. Truxton
Oct 3, 2016 Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... Class II West-Ward Pharmaceuticals Corp.
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.
May 13, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On... Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). Class III West-Ward Pharmaceutical Corp.
Oct 2, 2014 VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co... Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. Class II West-Ward Pharmaceutical Corp.
May 20, 2014 Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND... Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month ti... Class II West-Ward Pharmaceutical Corp.
Nov 7, 2013 Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward ... Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... Class II West-Ward Pharmaceutical Corp.
Sep 23, 2013 Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Do... Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d... Class II West-Ward Pharmaceutical Corp.
Sep 23, 2013 Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single D... Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d... Class II West-Ward Pharmaceutical Corp.
Jul 30, 2013 Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (N... Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other U... Class II West-Ward Pharmaceutical Corp.
Jul 30, 2013 Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10... Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets Class II West-Ward Pharmaceutical Corp.
Jun 4, 2013 VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tabl... Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification resu... Class II West-Ward Pharmaceutical Corp.
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets containe... Class II West-Ward Pharmaceutical Corp.
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks ... Class II West-Ward Pharmaceutical Corp.
May 13, 2013 Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use... Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpu... Class III West-ward Pharmaceutical Corp.
Mar 18, 2013 Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), R... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration... Class II West-ward Pharmaceutical Corp.
Mar 18, 2013 Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, ... Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. Class II West-ward Pharmaceutical Corp.
Feb 6, 2013 Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured fo... Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg... Class II West-ward Pharmaceutical Corp.
Jan 7, 2013 Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, U... Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. Class II West-ward Pharmaceutical Corp.
Jan 7, 2013 Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactu... Subpotent Drug Class III West-ward Pharmaceutical Corp.
Dec 7, 2012 Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottl... Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. Class II West-ward Pharmaceutical Corp.
Dec 7, 2012 Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bo... Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tab... Class II West-ward Pharmaceutical Corp.
Dec 7, 2012 Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (N... Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant ... Class II West-ward Pharmaceutical Corp.
Dec 5, 2012 PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the t... Class II West-ward Pharmaceutical Corp.
Dec 5, 2012 PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: A complaint was received for black specks identified as stainless ... Class II West-ward Pharmaceutical Corp.
Dec 4, 2012 Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-... Failed Dissolution Specifications; 36 month stability timepoint Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-c... Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 617... Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Regist... Class III West-ward Pharmaceutical Corp.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.

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.