Browse Drug Recalls
514 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 514 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 514 FDA drug recalls in AZ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2021 | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compound... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compound... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Jul 16, 2021 | ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distrib... | Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil | Class I | Alpha-Tek LLC |
| Aug 25, 2020 | Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, ... | Subpotent Drug: FDA analysis found product to be subpotent | Class I | RLC Labs Inc. |
| Aug 25, 2020 | Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levoth... | Subpotent Drug: FDA analysis found product to be subpotent | Class I | RLC Labs Inc. |
| Aug 25, 2020 | WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,... | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | Class II | RLC Labs Inc. |
| Aug 25, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 7... | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | Class II | RLC Labs Inc. |
| Aug 25, 2020 | Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Le... | Subpotent Drug: FDA analysis found product to be subpotent | Class I | RLC Labs Inc. |
| Aug 25, 2020 | WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a... | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | Class II | RLC Labs Inc. |
| Aug 25, 2020 | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,... | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | Class II | RLC Labs Inc. |
| Aug 25, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 1... | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | Class II | RLC Labs Inc. |
| Aug 25, 2020 | WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levo... | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | Class II | RLC Labs 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.