AvKARE recalls
Every recall we track for AvKARE — 20 in all, from 2024–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from AvKARE peaked in 2025 (10); 20 since 2017.
All FDA recall records for AvKARE 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 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 6 | 3 | 9 |
| 2025 | 0 | 0 | 6 | 4 | 10 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Most common reasons for AvKARE recalls
What to do if you have a recalled AvKARE 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 AvKARE recalls
14 shown- Lower riskDrug
AvKARE recalls Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN
AvKARE recalls 100 mg amantadine capsules due to failed dissolution specifications. This affects certain lots manufactured in Pulaski, TN. Consumers should contact the manufacturer for details.
AvKAREFeb 13, 2026 - Lower riskDrug
AvKARE recalls Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski,
AvKARE recalls 10mg Rosuvastatin tablets due to dissolution problems. This may affect medication effectiveness. Check NDC 50268-709-15 and lot #49124 for affected products.
AvKAREDec 31, 2025 - Lower riskDrug
AvKARE recalls Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units,
AvKARE recalls hormone tablets with failed content uniformity. These birth control pills may not deliver consistent hormone levels. Return unused tablets to your pharmacy.
AvKARESep 2, 2025 - UnratedDrug
AvKARE recalls chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for:
AvKARE recalls 50mg chloroproMAZINE hydrochloride tablets due to foreign substance presence. Rx-only medication with specific lot numbers and expiration dates.
AvKAREAug 25, 2025 - UnratedDrug
AvKARE recalls Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC:
AvKARE recalls 1 mg Pitavastatin tablets (Rx only) due to failed impurity and degradation specifications. Affected lots expire 10/31/2025 and 09/30/2026. Consumers should contact for details.
AvKAREJun 26, 2025 - Lower riskDrug
AvKARE recalls Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN
AvKARE recalls 200mg Celecoxib capsules due to foreign tablets found in some batches. Consumers should check product details and contact AvKARE for guidance.
AvKAREMay 13, 2025 - Lower riskDrug
AvKARE recalls Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE,
AvKARE recalls 25mg Chlorthalidone tablets due to failed dissolution specifications. This may affect medication effectiveness. Check your prescription for the specific lot and expiration date.
AvKAREMay 9, 2025 - Lower riskDrug
AvKARE recalls Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal
AvKARE recalls 8mg Silodosin capsules due to subpotent drug levels. This may affect prescription medication safety. Contact for details.
AvKAREFeb 4, 2025 - Lower riskDrug
AvKARE recalls Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478.
AvKARE recalls 300mg irbesartan tablets with dissolution issues. Check NDC 50268-442-15, Lot 45279, expiring 03/31/2025 for affected units.
AvKAREJan 21, 2025 - Lower riskDrug
AvKARE recalls Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles,
AvKARE recalls 0.5% moisturizing lubricant eye drops due to labeling mix-up. No immediate danger but check if you have the specific lot number.
AvKAREDec 18, 2024 - Lower riskDrug
AvKARE recalls Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE,
AvKARE recalls 100 mg Nitrofurantoin Capsules due to failed dissolution specifications. This may affect medication effectiveness. Check NDC# 50268-625-15 and lot # 47101 for affected units.
AvKAREDec 4, 2024 - UnratedDrug
AvKARE recalls Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
AvKARE recalls 60mg Cinacalcet tablets due to nitrosamine impurity exceeding safety limits. This medication, prescribed for high calcium levels, may pose health risks if taken.
AvKARENov 27, 2024 - Lower riskDrug
AvKARE recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC
AvKARE recalls 12.5 mg Sunitinib Malate Capsules (28-count) due to labeling mix-up. This may cause confusion with similar medications. No action needed per official notice.
AvKAREOct 18, 2024 - Lower riskDrug
AvKARE recalls Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE,
AvKARE recalls 20-unit Atovaquone Oral Suspension sachets due to potential Bacillus cereus contamination. This non-sterile product may cause illness if used.
AvKAREMar 28, 2024
AvKARE recall questions
How many recalls has AvKARE had?
20 recalls from AvKARE are on record with U.S. safety agencies, from 2024–2026.
What is the most recent AvKARE recall?
AvKARE recalls Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN, dated Feb 13, 2026. Every AvKARE recall is listed on this page, newest first.
Why are AvKARE products recalled?
The most common reasons on record: Failed Dissolution Specifications (2); Failed Impurity/Degradation Specifications (2); Labeling: Label Mix-Up (2); LABELING: LABEL MIX-UP (2).
What should I do if I have a recalled AvKARE 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 AvKARE 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.