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fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, Qu...

FDA Drug Recall #D-0553-2020 — Class II — November 12, 2019

Recall Summary

Recall Number D-0553-2020
Classification Class II — Moderate risk
Date Initiated November 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm QuVa Pharma, Inc.
Location Sugar Land, TX
Product Type Drugs

Product Description

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37

Reason for Recall

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Distribution Pattern

Nationwide.

Lot / Code Information

Lots: 10029202 Exp. 11/17/2019, 10029753 Exp. 11/17/2019, 10029756 Exp. 11/17/2019, 10029792 Exp. 11/18/2019, 10029793 Exp. 11/18/2019, 10029808 Exp. 11/18/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029757 Exp. 11/17/2019, 10029758 Exp. 11/17/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10029897 Exp. 11/20/2019, 10029793 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10030394 Exp. 11/25/2019, 10030395 Exp. 11/25/2019, 10030479 Exp. 11/27/2019, 10030480 Exp. 11/27/2019, 10030481 Exp. 11/27/2019, 10030449 Exp. 11/26/2019, 10030450 Exp. 11/26/2019, 10030451 Exp. 11/26/2019, 10030883 Exp. 12/2/2019, 10030885 Exp. 12/2/2019, 10030507 Exp. 11/27/2019, 10030508 Exp. 11/27/2019, 10030936 Exp. 12/3/2019, 10030937 Exp. 12/3/2019, 10030956 Exp. 12/3/2019, 10030903 Exp. 11/30/2019, 10030904 Exp. 11/30/2019, 10030988 Exp. 12/4/2019, 10030938 Exp. 12/3/2019, 10030955 Exp. 12/3/2019, 10030884 Exp. 11/30/2019, 10030902 Exp. 11/30/2019, 10030986 Exp. 12/4/2019, 10030987 Exp. 12/4/2019, 10031009 Exp. 12/4/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031150 Exp. 12/8/2019, 10031009 Exp. 12/4/2019, 10030506 Exp. 11/27/2019, 10030448 Exp. 11/26/2019, 10031176 Exp. 12/9/2019, 10031385 Exp. 12/9/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031149 Exp. 12/8/2019, 10031234 Exp. 12/10/2019, 10031235 Exp. 12/10/2019, 10031259 Exp. 12/10/2019, 10031261 Exp. 12/10/2019, 10031177 Exp. 12/9/2019, 10031384 Exp. 12/9/2019, 10030426 Exp. 11/26/2019, 10030427 Exp. 11/26/2019, 10031260 Exp. 12/10/2019, 10030957 Exp. 12/3/2019, 10031389 Exp. 12/11/2019, 10030957 Exp. 12/3/2019, 10030904 Exp. 11/30/2019, 10031502 Exp. 12/17/2019, 10031474 Exp. 12/16/2019, 10031503 Exp. 12/17/2019, 10031589 Exp. 12/19/2019, 10031611 Exp. 12/19/2019, 10031565 Exp. 12/18/2019, 10031502 Exp. 12/17/2019, 10031563 Exp. 12/17/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031730 Exp. 12/22/2019, 10031588 Exp. 12/19/2019, 10031589 Exp. 12/19/2019, 10031610 Exp. 12/19/2019, 10031564 Exp. 12/18/2019, 10031565 Exp. 12/18/2019, 10031785 Exp. 12/23/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031729 Exp. 12/22/2019, 10031640 Exp. 12/20/2019, 10031564 Exp. 12/18/2019, 10031786 Exp. 12/23/2019, 10031810 Exp. 12/23/2019, 10031893 Exp. 12/25/2019, 10031894 Exp. 12/25/2019, 10032247 Exp. 12/30/2019, 10032218 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031915 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031864 Exp. 12/24/2019, 10032217 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031842 Exp. 12/24/2019, 10032362 Exp. 1/1/2020, 10032363 Exp. 1/1/2020, 10032387 Exp. 1/1/2020, 10032304 Exp. 12/31/2019, 10032388 Exp. 1/1/2020, 10032554 Exp. 1/6/2020, 10032503 Exp. 1/5/2020, 10032504 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032580 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020

Other Recalls from QuVa Pharma, Inc.

Recall # Classification Product Date
D-0113-2026 Class II R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDi... Oct 10, 2025
D-0295-2025 Class II fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /... Mar 6, 2025
D-0296-2025 Class II fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /... Mar 6, 2025
D-0297-2025 Class II fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /... Mar 6, 2025
D-1544-2022 Class III oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added ... Sep 20, 2022

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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