Drug Safety & Recall Center
Live FDA recall alerts, what the recall classes actually mean, and exactly what to do if a medication you take gets recalled.
- Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Di — CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. (Class II, 2026-08-05)
- Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: N — Failed Dissolution Specifications (Class II, 2026-08-04)
- SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 4 — CGMP Deviations:Noted during FDA inspection (Class II, 2026-08-03)
- TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H — CGMP Deviations:Noted during FDA inspection (Class II, 2026-08-03)
- TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/ — CGMP Deviations:Noted during FDA inspection (Class II, 2026-08-03)
- SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 4 — CGMP Deviations:Noted during FDA inspection (Class II, 2026-08-03)
- TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ra — CGMP Deviations:Noted during FDA inspection (Class II, 2026-08-03)
- Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile So — Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. (Class I, 2026-07-31)
See the full FDA recalls & safety alerts list →
FDA openFDA enforcement — Updated 2026-08-29Medication recalls are more common than most people realize, and most don't make the news. This page tracks current FDA drug recalls in real time, explains what the recall classes actually mean, and — more importantly — tells you exactly what to do if something you take is on the list.
If your medication has been recalled, don't stop taking it on your own — call your pharmacist or prescriber first. Check the lot number and NDC on your prescription label against the recall notice, or call us at (860) 522-9289 and we'll check it against the current recall for you directly.
What "recall" actually means, and what it doesn't
A recall doesn't necessarily mean a medication is dangerous for everyone who's ever taken it. It means the FDA and the manufacturer have identified a problem — a contamination risk, an incorrect label, a dosing inconsistency, a packaging defect — usually tied to specific manufacturing lots, not every unit of that drug ever made. The FDA sorts every recall into one of three classes based on the severity of the risk:
| Class | What it means |
|---|---|
| Class I | Reasonable probability of serious adverse health consequences or death. The most serious category. |
| Class II | May cause temporary or medically reversible harm, or the probability of serious harm is remote. |
| Class III | Not likely to cause any adverse health consequences — often a labeling or packaging issue. |
Most recalls you'll see below are Class II or III. A Class I recall for a widely prescribed drug is uncommon, and when it happens it's genuinely urgent.
The recall list at the top of this page pulls directly from openFDA's enforcement database on a schedule — we don't hand-curate it, so it reflects what the FDA has actually published, not a filtered subset.
What to do if your medication is recalled
Don't stop taking it on your own. This is the single most important thing on this page. For a lot of recalls — an out-of-spec impurity level, a labeling error, a packaging defect — the risk of abruptly stopping a medication you need is often higher than the risk the recall itself is addressing. Call your pharmacist or prescriber before you do anything.
- Check the lot number and NDC on your label against the recall notice. Recalls are usually specific to certain manufacturing lots, not every bottle of that drug.
- Call us at (860) 522-9289 with your prescription label in hand — we can check it against the current recall directly and tell you within minutes whether it's affected.
- If it is affected, we'll arrange a replacement from an unaffected lot or an alternative, and coordinate with your prescriber if a therapy change is needed.
- If you've already had a reaction, tell us and your prescriber — and consider reporting it yourself (see below).
Recall vs. shortage — they're not the same thing
It's easy to conflate the two, but they mean very different things:
- A recall is a quality, safety, or labeling problem with a specific product or batch — the drug itself, as manufactured, has an issue.
- A shortage is a supply problem — the drug is temporarily hard to get, usually for manufacturing capacity or raw-material reasons, with nothing wrong with the product itself.
We track both separately. Shortage status for the medications we carry appears directly on each drug's page; recalls are tracked here, site-wide.
Report a problem yourself
You don't need a referral to tell the FDA about a side effect, a product quality issue, or a suspected counterfeit — MedWatch is the FDA's own reporting program for consumers and patients, and anyone can file a report directly. We're also always glad to help you file one, or to report it through our own channels if that's easier.
Check for medication interactions
Before combining medications — prescription, over-the-counter, or supplements — check for interactions. We recommend the Drug Interactions Checker from Drugs.com, an independent, pharmacist-reviewed reference. It's not a substitute for asking your pharmacist directly, but it's a useful first check.
Frequently asked questions
What does a Class I recall mean?
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III means adverse health consequences are not likely.
How do I know if my specific medication is affected by a recall?
Check the lot number and NDC (National Drug Code) on your prescription label against the recall notice — a recall is usually specific to certain lots or manufacturers, not every version of a drug. The fastest way is to call us with your prescription label in hand; we can check it against the current recall in a couple of minutes.
What should I do if my medication has been recalled?
Do not stop taking it on your own. Call your pharmacist or prescriber first — for many recalls (a labeling error or a contamination risk below the threshold that causes acute harm, for example) the risk of suddenly stopping a needed medication is higher than the risk from the recall itself. We can tell you whether your specific bottle is affected and arrange a replacement if it is.
Is a drug recall the same as a drug shortage?
No. A recall means a specific batch or product has a quality, safety, or labeling problem and is being removed from the market. A shortage means a drug is temporarily hard to obtain, usually for manufacturing or supply-chain reasons, with nothing wrong with the product itself. We flag both, separately, on each drug's page.
How do I report a side effect or problem with a medication?
You can report it yourself directly to the FDA through MedWatch, the FDA's safety reporting program for consumers and patients — no referral needed. You can also tell us, and we can help you file it or report it through our own channels.
Sources
- Recalls, Market Withdrawals, & Safety Alerts — U.S. Food and Drug Administration
- Recalls Background and Definitions — U.S. Food and Drug Administration
- openFDA Drug Enforcement Reports API — U.S. FDA
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program — U.S. FDA
- Drug Interactions Checker — Drugs.com