Browse Drug Recalls
18 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18 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 18 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 14, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... | Supterpotent Drug | Class II | Mckesson Corporation |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Feb 26, 2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... | Failed Stability Specifications | Class II | Mckesson Packaging Services |
| Jan 29, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... | Subpotent Drug: Out of specification for assay (stability testing) | Class III | Mckesson Packaging Services |
| Aug 28, 2017 | Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card... | Failed moisture limits: Out of specification for moisture content. | Class III | Mckesson Packaging Services |
| May 30, 2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Onl... | Failed Moisture Limits: Product tested out-of-specification for moisture content. | Class III | Mckesson Packaging Services |
| Feb 23, 2017 | Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 3... | Presence of Foreign Substance: foreign material found in the bulk inventory. | Class II | Mckesson Packaging Services |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| Sep 15, 2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto... | Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod... | Class III | Mckesson Packaging Services |
| Sep 8, 2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart... | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but... | Class III | Mckesson Packaging Services |
| Apr 12, 2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... | Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. | Class III | Mckesson Packaging Services |
| Jul 30, 2014 | Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: S... | Presence of Foreign Substance; tablets may contain stainless steel metal particulates | Class II | Mckesson Packaging Services |
| Jun 19, 2014 | Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ... | Failed Dissolution Specification; at the 12 month time interval. | Class III | Mckesson Packaging Services |
| Mar 3, 2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets ... | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | Class III | McKesson Packaging Services |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
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.