Browse Drug Recalls
24 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 24 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 24 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2021 | Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class III | Calvin Scott & Company, Inc. |
| Jan 15, 2021 | Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class I | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc.... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calv... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distrib... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distri... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distri... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distrib... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distribut... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & C... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-041... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Al... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, 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.