ANI Pharmaceuticals, Inc. recalls
Every recall we track for ANI Pharmaceuticals, Inc. — 13 in all, from 2020–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from ANI Pharmaceuticals, Inc. peaked in 2020 (6); 13 since 2017.
All FDA recall records for ANI Pharmaceuticals, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 6 | 0 | 6 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 4 | 5 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 1 | 0 | 1 | 2 |
Most common reasons for ANI Pharmaceuticals, Inc. recalls
What to do if you have a recalled ANI Pharmaceuticals, Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All ANI Pharmaceuticals, Inc. recalls
4 shown- UnratedDrug
ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI
ANI Pharmaceuticals recalls 10 mg/5 mL hydrOXYzine Hydrochloride Oral Solution (1 pint) due to foreign substance presence. Rx only product distributed by ANI Pharmaceuticals, Inc. in Baudette, MN. NDC: 70954-912-10, Lot S25133A.
ANI PharmaceuticalsJun 2, 2026 - Use cautionDrug
ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals,
ANI Pharmaceuticals recalls Estradiol Gel packets because some are empty or partially full. Check your lot number and expiration date for details.
ANI PharmaceuticalsMay 12, 2026 - UnratedDrug
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC
ANI Pharmaceuticals recalls 0.5mg Alprazolam tablets with specific NDC codes and expiration dates due to cGMP deviations. Affected products may not meet quality standards.
ANI PharmaceuticalsFeb 15, 2022 - Lower riskDrug
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
ANI Pharmaceuticals recalls 25mg amphetamine capsules with incorrect expiration date (labeled 24 months instead of 18 months). This affects certain prescription bottles manufactured in 2021. Consumers should check their product labels and contact the manufacturer for details.
ANI PharmaceuticalsOct 9, 2020
ANI Pharmaceuticals, Inc. recall questions
How many recalls has ANI Pharmaceuticals, Inc. had?
13 recalls from ANI Pharmaceuticals, Inc. are on record with U.S. safety agencies, from 2020–2026.
What is the most recent ANI Pharmaceuticals, Inc. recall?
ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI, dated Jun 2, 2026. Every ANI Pharmaceuticals, Inc. recall is listed on this page, newest first.
Why are ANI Pharmaceuticals, Inc. products recalled?
The most common reasons on record: cGMP Deviations (5).
What should I do if I have a recalled ANI Pharmaceuticals, Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new ANI Pharmaceuticals, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.